Trial Outcomes & Findings for Cannabidiol in the Treatment of Opioid Use Disorder (NCT NCT06206291)
NCT ID: NCT06206291
Last Updated: 2026-06-18
Results Overview
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Baseline and 4 weeks
Results posted on
2026-06-18
Participant Flow
Participant milestones
| Measure |
Methadone CBD 200mg, Then CBD 400mg
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
First Dosing Period: 4 Weeks
STARTED
|
32
|
30
|
8
|
6
|
|
First Dosing Period: 4 Weeks
COMPLETED
|
29
|
26
|
8
|
5
|
|
First Dosing Period: 4 Weeks
NOT COMPLETED
|
3
|
4
|
0
|
1
|
|
Second Dosing Period: 4 Weeks
STARTED
|
29
|
26
|
8
|
5
|
|
Second Dosing Period: 4 Weeks
COMPLETED
|
28
|
26
|
7
|
5
|
|
Second Dosing Period: 4 Weeks
NOT COMPLETED
|
1
|
0
|
1
|
0
|
|
No Medications Period: 4 Weeks
STARTED
|
28
|
26
|
7
|
5
|
|
No Medications Period: 4 Weeks
COMPLETED
|
27
|
26
|
7
|
5
|
|
No Medications Period: 4 Weeks
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Methadone CBD 200mg, Then CBD 400mg
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
First Dosing Period: 4 Weeks
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
First Dosing Period: 4 Weeks
Protocol Violation
|
3
|
2
|
0
|
1
|
|
First Dosing Period: 4 Weeks
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Second Dosing Period: 4 Weeks
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Second Dosing Period: 4 Weeks
Pregnancy
|
0
|
0
|
1
|
0
|
|
No Medications Period: 4 Weeks
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Cannabidiol in the Treatment of Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=32 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=30 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=6 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 10.6 • n=20 Participants
|
46.63 years
STANDARD_DEVIATION 12.7 • n=20 Participants
|
47.85 years
STANDARD_DEVIATION 12.3 • n=40 Participants
|
45.01 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
45.74 years
STANDARD_DEVIATION 11.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
63 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
28 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
48 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
24 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
25 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
21 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: Results provide for participants who responded to the respective cues at both timepoints.
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=29 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=26 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Visual Analog Scale for Craving (VASC)
Change in VASC in response to drug cue
|
0.07 score on a scale
Standard Deviation 2.2
|
0.04 score on a scale
Standard Deviation 1.1
|
0.13 score on a scale
Standard Deviation 1.0
|
-1.20 score on a scale
Standard Deviation 3.3
|
|
Change in Visual Analog Scale for Craving (VASC)
Change in VASC in response to neutral cue
|
0.54 score on a scale
Standard Deviation 1.8
|
0.31 score on a scale
Standard Deviation 1.6
|
0.25 score on a scale
Standard Deviation 0.5
|
-0.20 score on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Baseline and 4-weeksPopulation: Results provide for participants who responded to the respective cues at both timepoints.
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale from 0-10, with higher score indicating extreme anxiety.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=29 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=26 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Visual Analog Scale Anxiety (VASA)
Change in VASA in response to neutral cue
|
0.82 score on a scale
Standard Deviation 1.9
|
0.00 score on a scale
Standard Deviation 1.3
|
1.25 score on a scale
Standard Deviation 1.7
|
0.60 score on a scale
Standard Deviation 1.8
|
|
Change in Visual Analog Scale Anxiety (VASA)
Change in VASA in response to drug cue
|
-0.48 score on a scale
Standard Deviation 2.8
|
0.25 score on a scale
Standard Deviation 1.4
|
1.00 score on a scale
Standard Deviation 1.7
|
0.80 score on a scale
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: 4-weeksPopulation: Results provide for participants who provided urine sample at 4 weeks.
Percentage of participants with positive urine toxicology for illicit opioid use at 4 weeks.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=29 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=26 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Percentage of Participants With Positive Urine Toxicology
|
75.90 Percentage of participants
|
80.80 Percentage of participants
|
12.5 Percentage of participants
|
20.00 Percentage of participants
|
PRIMARY outcome
Timeframe: weekly for 8 weeks (Baseline, Week 1, 2, 3, 4, 5, 6, 7, and 8)Population: Result provided for participants who completed the assessment for the respective week.
Systematic Assessment for Treatment Emergent Events (SAFTEE) is used to measure safety and tolerability. SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total score ranges 0 - 168, higher scores indicate a higher level of side effect burden.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=32 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=30 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=6 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Baseline
|
0.03 score on a scale
Standard Deviation 0.2
|
0.03 score on a scale
Standard Deviation 0.2
|
0.00 score on a scale
Standard Deviation 0.00
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Week 1
|
0.16 score on a scale
Standard Deviation 0.5
|
0.39 score on a scale
Standard Deviation 0.8
|
0.25 score on a scale
Standard Deviation 0.5
|
0.50 score on a scale
Standard Deviation 0.8
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Week 3
|
0.00 score on a scale
Standard Deviation 0.00
|
0.08 score on a scale
Standard Deviation 0.3
|
0.00 score on a scale
Standard Deviation 0.0
|
0.00 score on a scale
Standard Deviation 0.0
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Week 4
|
0.03 score on a scale
Standard Deviation 0.2
|
0.04 score on a scale
Standard Deviation 0.2
|
0.00 score on a scale
Standard Deviation 0.0
|
0.00 score on a scale
Standard Deviation 0.0
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Week 5
|
0.31 score on a scale
Standard Deviation 0.6
|
0.46 score on a scale
Standard Deviation 0.9
|
0.13 score on a scale
Standard Deviation 0.4
|
0.00 score on a scale
Standard Deviation 0.0
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Week 6
|
0.14 score on a scale
Standard Deviation 0.4
|
0.15 score on a scale
Standard Deviation 0.5
|
0.38 score on a scale
Standard Deviation 0.5
|
0.00 score on a scale
Standard Deviation 0.0
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Week 7
|
0.00 score on a scale
Standard Deviation 0.0
|
0.04 score on a scale
Standard Deviation 0.2
|
0.13 score on a scale
Standard Deviation 0.5
|
0.20 score on a scale
Standard Deviation 0.4
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Week 8
|
0.11 score on a scale
Standard Deviation 0.4
|
0.19 score on a scale
Standard Deviation 0.5
|
0.13 score on a scale
Standard Deviation 0.4
|
0.00 score on a scale
Standard Deviation 0.0
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Week 2
|
0.07 score on a scale
Standard Deviation 0.4
|
0.11 score on a scale
Standard Deviation 0.3
|
0.13 score on a scale
Standard Deviation 0.4
|
0.20 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 4-weeks and 8-weeksPopulation: Results provide for participants with data for both timepoints.
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving). Higher score indicates more extreme craving.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=27 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=24 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=5 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Visual Analog Scale for Craving (VASC)
Change in VASC in response to neutral cue
|
0.37 score on a scale
Standard Deviation 1.3
|
-0.08 score on a scale
Standard Deviation 0.8
|
0.00 score on a scale
Standard Deviation 0.0
|
0.40 score on a scale
Standard Deviation 0.5
|
|
Change in Visual Analog Scale for Craving (VASC)
Change in VASC in response to drug cue
|
-0.59 score on a scale
Standard Deviation 2.1
|
-0.21 score on a scale
Standard Deviation 0.9
|
-0.40 score on a scale
Standard Deviation 0.9
|
-0.20 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 4-weeks and 8-weeksPopulation: Results provide for participants with data for both timepoints.
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale: 0 (not at all anxious) - 10 (extremely anxious). Higher score indicates more extreme anxiety.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=27 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=24 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=5 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Visual Analog Scale Anxiety (VASA)
Change in VASA in response to neutral cue
|
0.22 score on a scale
Standard Deviation 1.8
|
0.04 score on a scale
Standard Deviation 1.5
|
-1.00 score on a scale
Standard Deviation 2.2
|
1.60 score on a scale
Standard Deviation 2.7
|
|
Change in Visual Analog Scale Anxiety (VASA)
Change in VASA in response to drug cue
|
-0.48 score on a scale
Standard Deviation 2.8
|
0.25 score on a scale
Standard Deviation 1.4
|
1.00 score on a scale
Standard Deviation 1.7
|
0.80 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 4 weeks and 8 weeksPopulation: Results provide for participants with data for both timepoints.
Proportion of percentage with positive urine toxicology for illicit opioid use at 8 weeks as compared to 4 weeks.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=28 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=26 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Percentage of Participants With Positive Urine Toxicology
|
-4.5 Percentage of participants
|
-3.9 Percentage of participants
|
25 Percentage of participants
|
-20 Percentage of participants
|
SECONDARY outcome
Timeframe: baseline and 4-weeks, 4-weeks and 8-weeksPopulation: Results provide for participants with data for specified timepoints.
Heroin Craving Questionnaire Short Form (HCQ-SF-14): A 15 minute, 14 item self-administered to measure general heroin craving. Each item is rated on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). Full scale ranges from 14-98, with higher scores indicating more severe heroin craving.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=27 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=25 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=7 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14)
between baseline and week 4
|
-0.24 score on a scale
Standard Deviation 1.1
|
-0.26 score on a scale
Standard Deviation 0.8
|
-0.48 score on a scale
Standard Deviation 0.7
|
-0.60 score on a scale
Standard Deviation 0.3
|
|
Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14)
between week 4 and week 8
|
-0.11 score on a scale
Standard Deviation 0.8
|
-0.20 score on a scale
Standard Deviation 0.7
|
-0.11 score on a scale
Standard Deviation 0.5
|
0.04 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and 4-weeks, 4-weeks and 8-weeksPopulation: Results provide for participants with data for specified timepoints.
The General Anxiety Disorder 7-item questionnaire (GAD-7) assesses seven problem items potentially experienced over the past two weeks from "0" (not at all) to "3" (nearly every day). Individuals rank their levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more anxiety symptoms.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=29 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=26 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Generalized Anxiety Disorder Scale (GAD-7)
between baseline and wee 4
|
0.00 score on a scale
Standard Deviation 4.5
|
-1.42 score on a scale
Standard Deviation 2.8
|
-3.38 score on a scale
Standard Deviation 4.7
|
-2.40 score on a scale
Standard Deviation 2.3
|
|
Change in Generalized Anxiety Disorder Scale (GAD-7)
between week 4 and week 8
|
-1.41 score on a scale
Standard Deviation 3.5
|
-0.32 score on a scale
Standard Deviation 2.8
|
-0.33 score on a scale
Standard Deviation 2.6
|
2.80 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: any time during study, 8 weeksPopulation: Results only include participants who started with positive urine toxicology for illicit opioids at baseline.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=23 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=19 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=1 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=2 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Duration of Participant First Illicit Opioid Abstinence
|
6.48 weeks
Standard Deviation 2.5
|
6.26 weeks
Standard Deviation 2.5
|
8.00 weeks
Standard Deviation NA
only one participant so no measure of dispersion
|
1.00 weeks
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: baseline and 4-weeks, 4-weeks and 8-weeksPopulation: Results provide for participants with data for specified timepoints.
The Questionnaire Type 9 for Depression (PHQ-9) measures depression severity with the nine DSM-IV criteria scored as "0" (not at all) to "3" (nearly every day). Full scale ranges from 0-27, with higher score indicating more severe symptoms.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=29 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=26 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Patient Health Questionnaire (PHQ-9)
between baseline and week 4
|
-1.21 score on a scale
Standard Deviation 4.9
|
-1.42 score on a scale
Standard Deviation 4.5
|
-3.13 score on a scale
Standard Deviation 4.1
|
-2.40 score on a scale
Standard Deviation 3.0
|
|
Change in Patient Health Questionnaire (PHQ-9)
between week 4 and week 8
|
-2.52 score on a scale
Standard Deviation 5.5
|
-0.72 score on a scale
Standard Deviation 3.6
|
-0.50 score on a scale
Standard Deviation 1.5
|
1.80 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: baseline, 4-weeks and 8-weeks, post-cue collected within 10 minutes of pre-cuePopulation: Results provide for participants with data for specified timepoints.
A 20 item self-administered questionnaire evaluating current positive and negative affect. Each item is rated on a 5-point scale (0= Very slightly or not at all, 5= Extremely). Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=32 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=30 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=6 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Positive and Negative Affect Schedule (PANAS-SF)
baseline positive pre cue first session
|
29.90 score on a scale
Standard Deviation 8.6
|
28.77 score on a scale
Standard Deviation 8.8
|
33.38 score on a scale
Standard Deviation 10.5
|
25.17 score on a scale
Standard Deviation 11.8
|
|
Positive and Negative Affect Schedule (PANAS-SF)
baseline positive post cue first session
|
29.44 score on a scale
Standard Deviation 9.6
|
28.03 score on a scale
Standard Deviation 8.8
|
32.13 score on a scale
Standard Deviation 8.7
|
23.00 score on a scale
Standard Deviation 13.5
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Baseline positive pre cue second session
|
28.31 score on a scale
Standard Deviation 9.3
|
28.90 score on a scale
Standard Deviation 9.7
|
30.50 score on a scale
Standard Deviation 9.5
|
21.00 score on a scale
Standard Deviation 13.1
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Baseline positive post cue second session
|
28.56 score on a scale
Standard Deviation 10.1
|
27.20 score on a scale
Standard Deviation 9.8
|
31.13 score on a scale
Standard Deviation 12.6
|
22.33 score on a scale
Standard Deviation 15.0
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 4 positive pre cue first session
|
29.52 score on a scale
Standard Deviation 7.7
|
31.31 score on a scale
Standard Deviation 9.2
|
32.13 score on a scale
Standard Deviation 14.1
|
26.60 score on a scale
Standard Deviation 14.7
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 4 positive post cue first session
|
28.34 score on a scale
Standard Deviation 7.9
|
29.77 score on a scale
Standard Deviation 9.9
|
32.50 score on a scale
Standard Deviation 14.0
|
23.00 score on a scale
Standard Deviation 14.7
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 4 positive pre cue second session
|
28.07 score on a scale
Standard Deviation 7.9
|
30.00 score on a scale
Standard Deviation 9.3
|
31.50 score on a scale
Standard Deviation 13.9
|
22.40 score on a scale
Standard Deviation 15.9
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 4 positive post cue second session
|
28.10 score on a scale
Standard Deviation 9.5
|
29.65 score on a scale
Standard Deviation 9.7
|
30.88 score on a scale
Standard Deviation 14.5
|
22.00 score on a scale
Standard Deviation 16.3
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 8 positive pre cue first session
|
29.00 score on a scale
Standard Deviation 9.1
|
28.46 score on a scale
Standard Deviation 11.2
|
38.60 score on a scale
Standard Deviation 7.4
|
23.80 score on a scale
Standard Deviation 13.3
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 8 positive post cue first session
|
28.22 score on a scale
Standard Deviation 9.3
|
25.79 score on a scale
Standard Deviation 12.3
|
31.00 score on a scale
Standard Deviation 6.9
|
24.20 score on a scale
Standard Deviation 13.7
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 8 positive pre cue second session
|
28.67 score on a scale
Standard Deviation 10.3
|
27.17 score on a scale
Standard Deviation 12.3
|
34.60 score on a scale
Standard Deviation 7.5
|
22.60 score on a scale
Standard Deviation 15.1
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 8 positive post cue second session
|
27.04 score on a scale
Standard Deviation 10.5
|
28.21 score on a scale
Standard Deviation 12.4
|
34.20 score on a scale
Standard Deviation 7.4
|
22.20 score on a scale
Standard Deviation 14.7
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Baseline negative pre cue first session
|
14.48 score on a scale
Standard Deviation 4.6
|
13.53 score on a scale
Standard Deviation 4.8
|
14.88 score on a scale
Standard Deviation 4.6
|
10.67 score on a scale
Standard Deviation 0.8
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Baseline negative post cue first session
|
14.25 score on a scale
Standard Deviation 5.1
|
13.07 score on a scale
Standard Deviation 3.8
|
13.63 score on a scale
Standard Deviation 2.4
|
13.17 score on a scale
Standard Deviation 6.8
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Baseline negative pre cue second session
|
13.06 score on a scale
Standard Deviation 3.8
|
12.23 score on a scale
Standard Deviation 3.7
|
11.38 score on a scale
Standard Deviation 1.3
|
10.67 score on a scale
Standard Deviation 0.8
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Baseline negative post cue second session
|
14.66 score on a scale
Standard Deviation 4.3
|
12.13 score on a scale
Standard Deviation 3.1
|
11.38 score on a scale
Standard Deviation 1.9
|
11.67 score on a scale
Standard Deviation 2.4
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 4 negative pre cue first session
|
13.21 score on a scale
Standard Deviation 4.8
|
13.38 score on a scale
Standard Deviation 6.2
|
15.50 score on a scale
Standard Deviation 9.4
|
11.20 score on a scale
Standard Deviation 2.2
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 4 negative post cue first session
|
13.66 score on a scale
Standard Deviation 5.2
|
13.12 score on a scale
Standard Deviation 5.7
|
14.13 score on a scale
Standard Deviation 7.8
|
11.40 score on a scale
Standard Deviation 1.9
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 4 negative pre cue second session
|
12.21 score on a scale
Standard Deviation 3.8
|
12.31 score on a scale
Standard Deviation 5.5
|
13.25 score on a scale
Standard Deviation 6.5
|
10.60 score on a scale
Standard Deviation 0.9
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 4 negative post cue second session
|
13.48 score on a scale
Standard Deviation 5.1
|
13.12 score on a scale
Standard Deviation 5.9
|
13.38 score on a scale
Standard Deviation 7.3
|
12.20 score on a scale
Standard Deviation 2.9
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 8 negative pre cue first session
|
12.37 score on a scale
Standard Deviation 3.2
|
13.46 score on a scale
Standard Deviation 6.8
|
10.60 score on a scale
Standard Deviation 0.9
|
13.60 score on a scale
Standard Deviation 5.0
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 8 negative pre cue second session
|
12.07 score on a scale
Standard Deviation 3.2
|
13.83 score on a scale
Standard Deviation 8.6
|
10.20 score on a scale
Standard Deviation 0.4
|
13.40 score on a scale
Standard Deviation 7.1
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 8 negative post cue second session
|
12.78 score on a scale
Standard Deviation 4.4
|
13.25 score on a scale
Standard Deviation 8.2
|
10.40 score on a scale
Standard Deviation 0.9
|
13.20 score on a scale
Standard Deviation 6.6
|
|
Positive and Negative Affect Schedule (PANAS-SF)
Week 8 negative post cue first session
|
14.14 score on a scale
Standard Deviation 5.6
|
13.58 score on a scale
Standard Deviation 8.0
|
11.00 score on a scale
Standard Deviation 1.7
|
14.20 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: baseline and 8-weeksPopulation: Results provide for participants with data for both timepoints.
Heart rate (beats/min) will be monitored throughout the time course of the study and change at Week 8 from baseline will be studied.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=27 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=25 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=6 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Heart Rate
|
-0.70 beats per min
Standard Deviation 11.8
|
0.52 beats per min
Standard Deviation 9.7
|
-4.67 beats per min
Standard Deviation 11.5
|
-6.20 beats per min
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: baseline and 8-weeksPopulation: Results provide for participants with data for both timepoints.
Blood pressure (in mmHg) will be monitored throughout the time course of the study and changes at week 8 as compared from baseline will be studied. Both diastolic and systolic pressures will be assessed.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=27 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=25 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=6 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Blood Pressure
diastolic
|
0.81 mmHg
Standard Deviation 14.1
|
0.28 mmHg
Standard Deviation 14.4
|
-2.00 mmHg
Standard Deviation 14.1
|
0.60 mmHg
Standard Deviation 16.6
|
|
Change in Blood Pressure
systolic
|
-5.33 mmHg
Standard Deviation 19.5
|
1.40 mmHg
Standard Deviation 14.8
|
-8.83 mmHg
Standard Deviation 13.5
|
-1.20 mmHg
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: baseline and 8-weeksPopulation: Results provide for participants with both for specified timepoints.
Body temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes at week 8 from baseline will be studied.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=27 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=25 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=6 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Body Temperature
|
-0.44 degrees in Fahrenheit
Standard Deviation 2.1
|
-0.01 degrees in Fahrenheit
Standard Deviation 1.0
|
0.52 degrees in Fahrenheit
Standard Deviation 1.1
|
0.14 degrees in Fahrenheit
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: baseline and 8-weeksPopulation: Results provide for participants with data for both timepoints.
Oxygen level will be measured by pulse oximetry when vitals are collected. Change in oxygen level at week 8 as compared to baseline
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=27 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=25 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=6 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Oxygen Level
|
-1.37 percentage of SP02
Standard Deviation 3.5
|
-0.24 percentage of SP02
Standard Deviation 3.5
|
0.00 percentage of SP02
Standard Deviation 1.8
|
0.40 percentage of SP02
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline and 4-weeks, 4-weeks and 8-weeksStudy participant will chew on a cotton swab providing a saliva sample from which free cortisol levels will be measured as an indicator of stress response in association with video cues. Thus, the stress of craving will be monitored and measured to observe any neutral cue induced changes from between baseline and 4 weeks, and between 4 weeks and 8 weeks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 8-weeksPopulation: Results provide for participants who provided data.
Average sleep duration measured across 8 weeks.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=15 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=9 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=4 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=2 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Sleep Duration in Minutes Per Night
|
359.87 minutes per night
Standard Deviation 108.19
|
378.23 minutes per night
Standard Deviation 57.47
|
412.7 minutes per night
Standard Deviation 55.44
|
397.76 minutes per night
Standard Deviation 205.26
|
SECONDARY outcome
Timeframe: baseline and 8-weeksPopulation: Results provide for participants with data for both timepoints.
A 5-10 minute, 7 question self-administered screening tool for insomnia. Each item rates the nature and symptoms of potential sleep problems using a 5-point Likert-type scale. Minimum score of 0 and maximum score of 28, with the highest score indicating prevalence and severity of insomnia.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=26 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=25 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=6 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=3 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Insomnia Severity Index (ISI)
|
-2.96 score on a scale
Standard Deviation 5.7
|
-3.28 score on a scale
Standard Deviation 4.2
|
-5.33 score on a scale
Standard Deviation 9.6
|
-4.33 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: baseline and 8-weeksPopulation: Results provide for participants with data for both timepoints.
A 10-15 minute 30-item assessment that includes Digit Span Forward (DSF) and Digit Span Backward (DSB). DSF measures short-term memory, not working memory. DSB measures auditory working memory. Full scale from a minimum score of 0 and maximum score of 30, with the highest score indicating the total number of points achieved for correct responses.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=23 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=24 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=5 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in The Digit Span Test Subtest of the Wechsler Adult Intelligence Scale 4th Edition
|
0.09 score on a scale
Standard Deviation 2.3
|
0.29 score on a scale
Standard Deviation 2.0
|
1.00 score on a scale
Standard Deviation 2.0
|
-0.40 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: baseline and 8-weeksPopulation: Results provide for participants with data for both timepoints.
The Symptom Check List 90 (SCL-90): A 12-15 minute, 90 item self-administered psychometric instrument yielding nine scores of primary symptom dimensions (5-point rating scale; 1= Not at all, 5= Extremely), along with three scores based on global distress measures. Full scale ranges from a minimum score of 90 and maximum score of 450, with higher scores indicating more severe psychological distress.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=27 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=25 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=6 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in The Symptom Check List 90 (SCL-90)
|
-10.11 score on a scale
Standard Deviation 33.7
|
-17.08 score on a scale
Standard Deviation 36.1
|
-51.33 score on a scale
Standard Deviation 65.3
|
-8.60 score on a scale
Standard Deviation 37.3
|
SECONDARY outcome
Timeframe: baseline and 4-weeks, 4-weeks and 8 weeksPopulation: Results provide for participants with data for specified timepoints.
Change in percentage of participants with THC positive in Urine - Substance use other than opioids measured in urine.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=29 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=26 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Percentage of Participants With THC Positive in Urine.
baseline and week 4
|
52 Percentage of participants
|
0 Percentage of participants
|
50 Percentage of participants
|
-27 Percentage of participants
|
|
Change in Percentage of Participants With THC Positive in Urine.
week 4 and week 8
|
-7 Percentage of participants
|
38 Percentage of participants
|
0 Percentage of participants
|
60 Percentage of participants
|
SECONDARY outcome
Timeframe: baseline and 4-weeks, 4-weeks and 8 weeksPopulation: Results provide for participants with data for specified timepoints.
Change in plasma level THC Positive in - Substance use other than opioids measured in blood.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=26 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=21 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=6 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Plasma Level of THC Positive in Blood.
between baseline and week 4
|
1.82 ng/ml
Standard Deviation 10.6
|
8.34 ng/ml
Standard Deviation 37.6
|
0.13 ng/ml
Standard Deviation 1.2
|
6.30 ng/ml
Standard Deviation 17.9
|
|
Change in Plasma Level of THC Positive in Blood.
between week 4 and week 8
|
6.61 ng/ml
Standard Deviation 34.3
|
-7.07 ng/ml
Standard Deviation 39.6
|
0.00 ng/ml
Standard Deviation 0.0
|
2.08 ng/ml
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: baseline and 4-weeks, 4-weeks and 8-weeksPopulation: Results provide for participants with data for specified timepoints.
Concentration of methadone metabolites measured in blood.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=26 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=21 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Concentration of Methadone Metabolites in Blood
between week 4 and week 8
|
-18.41 ng/ml
Standard Deviation 322.6
|
-155.14 ng/ml
Standard Deviation 313.2
|
—
|
—
|
|
Change in Concentration of Methadone Metabolites in Blood
between baseline and week 4
|
-59.50 ng/ml
Standard Deviation 251.0
|
59.36 ng/ml
Standard Deviation 300.8
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 4-weeks, 4-weeks and 8 weeksPopulation: Results provide for participants with data for specified timepoints.
Concentration of buprenorphine metabolites measured in blood.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=6 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change in Concentration of Buprenorphine Metabolites in Blood
between week 4 and week 8
|
-0.97 ng/ml
Standard Deviation 1.5
|
-0.79 ng/ml
Standard Deviation 3.8
|
—
|
—
|
|
Change in Concentration of Buprenorphine Metabolites in Blood
between baseline and week 4
|
0.20 ng/ml
Standard Deviation 2.2
|
1.45 ng/ml
Standard Deviation 2.8
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 8 weeksRetention in treatment as measured by number of participants remaining in treatment.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=32 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=30 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=8 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=6 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Number of Participants Remaining in Treatment
|
28 Participants
|
26 Participants
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: baseline and 8 weeksPopulation: Results provide for participants with data for both timepoints.
Change in the methadone dosage at Week 8 as compared to baseline.
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=27 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=25 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Change Methadone Dosage of Opioid Agonist Treatment
|
3.37 mg
Standard Deviation 8.5
|
2.40 mg
Standard Deviation 9.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Data for participants who provided blood specimen
The number of CBD-COOH positive blood toxicology to measure adherence
Outcome measures
| Measure |
Methadone CBD 200mg, Then CBD 400mg
n=26 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo, Then CBD 400mg
n=22 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg, Then CBD 400mg
n=6 Participants
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo, Then CBD 400mg
n=5 Participants
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Placebo: Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|
|
Number of CBD-COOH Positive Blood Toxicology
|
25 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
Adverse Events
Methadone CBD 200mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Methadone Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Methadone CBD 400mg
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Buprenorphine CBD 200mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Buprenorphine Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Buprenorphine CBD 400mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methadone CBD 200mg
n=32 participants at risk
Cannabidiol (CBD) 200mg for First 4 weeks twice daily adjunct with opioid agonist treatment.
|
Methadone Placebo
n=30 participants at risk
Matching placebo twice daily for first 4 weeks daily adjunct with opioid agonist treatment.
|
Methadone CBD 400mg
n=55 participants at risk
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 200mg
n=8 participants at risk
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Cannabidiol (CBD) 200mg for First 4 weeks twice daily adjunct with opioid agonist treatment.
|
Buprenorphine Placebo
n=6 participants at risk
Matching placebo twice daily for first 4 weeks daily adjunct with opioid agonist treatment.
|
Buprenorphine CBD 400mg
n=13 participants at risk
Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Insomnia
|
0.00%
0/32 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
1.8%
1/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • 8 weeks
|
10.0%
3/30 • 8 weeks
|
0.00%
0/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
16.7%
1/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/32 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
1.8%
1/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • 8 weeks
|
3.3%
1/30 • 8 weeks
|
1.8%
1/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.1%
1/32 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
1.8%
1/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Eye disorders
Dry Eyes
|
0.00%
0/32 • 8 weeks
|
3.3%
1/30 • 8 weeks
|
0.00%
0/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/32 • 8 weeks
|
6.7%
2/30 • 8 weeks
|
1.8%
1/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
General disorders
Fever
|
0.00%
0/32 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
1.8%
1/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/32 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
5.5%
3/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Nervous system disorders
Nightmares
|
0.00%
0/32 • 8 weeks
|
10.0%
3/30 • 8 weeks
|
3.6%
2/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Gastrointestinal disorders
Loose Stool
|
3.1%
1/32 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
2/32 • 8 weeks
|
10.0%
3/30 • 8 weeks
|
21.8%
12/55 • 8 weeks
|
12.5%
1/8 • 8 weeks
|
33.3%
2/6 • 8 weeks
|
7.7%
1/13 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
9.4%
3/32 • 8 weeks
|
16.7%
5/30 • 8 weeks
|
10.9%
6/55 • 8 weeks
|
12.5%
1/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
7.7%
1/13 • 8 weeks
|
|
General disorders
Fatigue
|
12.5%
4/32 • 8 weeks
|
6.7%
2/30 • 8 weeks
|
10.9%
6/55 • 8 weeks
|
25.0%
2/8 • 8 weeks
|
16.7%
1/6 • 8 weeks
|
30.8%
4/13 • 8 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • 8 weeks
|
3.3%
1/30 • 8 weeks
|
3.6%
2/55 • 8 weeks
|
12.5%
1/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Gastrointestinal disorders
Increased appetite
|
0.00%
0/32 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
1.8%
1/55 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
Additional Information
Yasmin Hurd, PhD
Icahn School of Medicine at Mount Sinai
Phone: 212-824-9314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place