Trial Outcomes & Findings for Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain (NCT NCT04827992)
NCT ID: NCT04827992
Last Updated: 2026-06-24
Results Overview
Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
Week 24
Results posted on
2026-06-24
Participant Flow
Recruitment took place at three academic medical centers in the Northeastern United States (Massachusetts General Hospital, Boston, MA; Cambridge Health Alliance, Cambridge, MA; Maine Medical Center, Portland, ME).
Participant milestones
| Measure |
Cannabis (CB)
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
45
|
|
Overall Study
COMPLETED
|
42
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Total number of participants analyzed for this baseline measure is 84 due to missing data for two participants in the CB group and one participant in the WL group.
Baseline characteristics by cohort
| Measure |
Cannabis (CB)
n=42 Participants
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=45 Participants
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 Years
STANDARD_DEVIATION 10.6 • n=42 Participants
|
57.6 Years
STANDARD_DEVIATION 9.9 • n=45 Participants
|
57.1 Years
STANDARD_DEVIATION 10.2 • n=87 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=42 Participants
|
27 Participants
n=45 Participants
|
54 Participants
n=87 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=42 Participants
|
18 Participants
n=45 Participants
|
33 Participants
n=87 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=42 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=87 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=42 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=87 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=42 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=87 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=42 Participants
|
3 Participants
n=45 Participants
|
5 Participants
n=87 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=42 Participants
|
36 Participants
n=45 Participants
|
75 Participants
n=87 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=42 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=87 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=42 Participants
|
4 Participants
n=45 Participants
|
5 Participants
n=87 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=42 Participants
|
3 Participants
n=45 Participants
|
6 Participants
n=87 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=42 Participants
|
41 Participants
n=45 Participants
|
80 Participants
n=87 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=42 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=87 Participants
|
|
Prescription Monitoring Program-verified daily opioid dose
|
96.8 Morphine milligram equivalents (MME)/day
STANDARD_DEVIATION 113 • n=42 Participants
|
99.7 Morphine milligram equivalents (MME)/day
STANDARD_DEVIATION 120.6 • n=45 Participants
|
98.3 Morphine milligram equivalents (MME)/day
STANDARD_DEVIATION 116 • n=87 Participants
|
|
Opioid use disorder (OUD) symptoms
|
1.6 Number of symptoms
STANDARD_DEVIATION 1.5 • n=40 Participants • Total number of participants analyzed for this baseline measure is 84 due to missing data for two participants in the CB group and one participant in the WL group.
|
1.5 Number of symptoms
STANDARD_DEVIATION 1.4 • n=44 Participants • Total number of participants analyzed for this baseline measure is 84 due to missing data for two participants in the CB group and one participant in the WL group.
|
1.5 Number of symptoms
STANDARD_DEVIATION 1.4 • n=84 Participants • Total number of participants analyzed for this baseline measure is 84 due to missing data for two participants in the CB group and one participant in the WL group.
|
|
Pain, Enjoyment, and General Activity (PEG) Scale Score
|
5.68 Score
STANDARD_DEVIATION 1.82 • n=40 Participants • Statistics correspond to analyzed cohort with available baseline data, missing or excluded n=2 (4.8%) in cannabis group and n=9 (20%) in waitlist group.
|
5.66 Score
STANDARD_DEVIATION 1.95 • n=36 Participants • Statistics correspond to analyzed cohort with available baseline data, missing or excluded n=2 (4.8%) in cannabis group and n=9 (20%) in waitlist group.
|
5.67 Score
STANDARD_DEVIATION 1.87 • n=76 Participants • Statistics correspond to analyzed cohort with available baseline data, missing or excluded n=2 (4.8%) in cannabis group and n=9 (20%) in waitlist group.
|
PRIMARY outcome
Timeframe: Week 24Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.
Outcome measures
| Measure |
Cannabis (CB)
n=42 Participants
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=45 Participants
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Mean Difference in Prescription Monitoring Program Verified Opioid Dose at Baseline and Week 24
|
113.3 MME/day
Interval 84.7 to 141.9
|
97.9 MME/day
Interval 70.2 to 125.6
|
PRIMARY outcome
Timeframe: Every post-baseline day until week 24Population: One participant from the CB group and eight participants from the WL group were excluded due to them completing less than 14 days of daily surveys.
The Pain, Enjoyment, General Activity (PEG) scale assesses pain intensity and interference. The scale ranges from 0 to 10, with a higher score indicating greater pain intensity and interference. PEG score was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Outcome measures
| Measure |
Cannabis (CB)
n=41 Participants
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=37 Participants
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score Over Post-baseline to Week 24 Interval
|
5.35 score
Interval 4.98 to 5.73
|
5.30 score
Interval 4.89 to 5.72
|
SECONDARY outcome
Timeframe: Every post-baseline day until week 24Population: One participant from the CB group and eight participants from the WL group were excluded due to not completing at least 14 days of daily surveys.
Self-reported opioid dose in morphine milligram equivalents (MME) per day. Self-reported opioid dose was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Outcome measures
| Measure |
Cannabis (CB)
n=41 Participants
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=37 Participants
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Mean Difference in Self-Reported Opioid Dose Over Post-baseline to Week 24 Interval
|
84.0 MME/day
Interval 68.4 to 99.6
|
89.6 MME/day
Interval 71.1 to 108.0
|
SECONDARY outcome
Timeframe: Week 4, week 8, week 12, week 16, week 20, week 24Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form assesses changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life. Q-LES-SF score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Outcome measures
| Measure |
Cannabis (CB)
n=42 Participants
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=45 Participants
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at Weeks 4, 8, 12, 16, 20, 24
|
45.5 Raw score
Interval 42.9 to 48.0
|
47.3 Raw score
Interval 44.6 to 49.9
|
SECONDARY outcome
Timeframe: Week 4, week 8, week 12, week 16, week 20, week 24The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression. PROMIS-29 depression subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Outcome measures
| Measure |
Cannabis (CB)
n=42 Participants
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=45 Participants
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Mean Difference in PROMIS-29 Depression Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24
|
52.7 score
Interval 50.8 to 54.5
|
52.4 score
Interval 50.5 to 54.3
|
SECONDARY outcome
Timeframe: Week 4, week 8, week 12, week 16, week 20, week 24The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety. PROMIS-29 anxiety subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Outcome measures
| Measure |
Cannabis (CB)
n=42 Participants
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=45 Participants
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24
|
53.2 score
Interval 51.2 to 55.3
|
50.1 score
Interval 48.0 to 52.1
|
SECONDARY outcome
Timeframe: Week 4, week 8, week 12, week 16, week 20, week 24Number of opioid use disorder (OUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. As all participants were taking prescribed opioids under the supervision of a clinician, symptom counts exclude tolerance and withdrawal. Number of symptoms range from 0 to 9. A score of 2 or more indicates a current opioid use disorder diagnosis. Number of opioid use disorder symptoms were assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Outcome measures
| Measure |
Cannabis (CB)
n=42 Participants
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=45 Participants
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Mean Difference in Opioid Use Disorder Symptoms at Weeks 4, 8, 12, 16, 20, 24
|
1.14 Number of symptoms
Interval 0.82 to 1.47
|
1.27 Number of symptoms
Interval 0.93 to 1.61
|
SECONDARY outcome
Timeframe: Week 12, Week 24Number of cannabis use disorder (CUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. Number of symptoms range from 0 to 11. A score of 2 or more indicates a current cannabis use disorder diagnosis. The number of cannabis use disorder symptoms were assessed at weeks 12 and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Outcome measures
| Measure |
Cannabis (CB)
n=42 Participants
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=45 Participants
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Mean Difference in Cannabis Use Disorder Symptoms at Weeks 12 and 24
|
0.54 Number of symptoms
Interval 0.36 to 0.72
|
0.03 Number of symptoms
Interval -0.13 to 0.19
|
Adverse Events
Cannabis (CB)
Serious events: 7 serious events
Other events: 36 other events
Deaths: 0 deaths
Waitlist (WL)
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cannabis (CB)
n=42 participants at risk
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=45 participants at risk
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
Surgical and medical procedures
Intrathecal Pump Insertion
|
0.00%
0/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
2.2%
1/45 • Number of events 2 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
2.2%
1/45 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Product Issues
Catheter Blockage
|
0.00%
0/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
2.2%
1/45 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Musculoskeletal and connective tissue disorders
Cervical disk herniation
|
0.00%
0/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
2.2%
1/45 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.4%
1/42 • Number of events 2 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Injury, poisoning and procedural complications
Dog bite
|
2.4%
1/42 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Surgical and medical procedures
Hospitalizations
|
2.4%
1/42 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
2.2%
1/45 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Surgical and medical procedures
Knee replacement surgery
|
0.00%
0/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
2.2%
1/45 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
General disorders
Opiate withdrawal symptoms
|
2.4%
1/42 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Infections and infestations
Osteomyelitis (acute)
|
2.4%
1/42 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.4%
1/42 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Nervous system disorders
Transient ischemic attack
|
2.4%
1/42 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
2.2%
1/45 • Number of events 1 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
Other adverse events
| Measure |
Cannabis (CB)
n=42 participants at risk
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
Waitlist (WL)
n=45 participants at risk
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
|
|---|---|---|
|
General disorders
Pain and discomfort
|
31.0%
13/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
35.6%
16/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Psychiatric disorders
Anxiety symptoms
|
28.6%
12/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
8.9%
4/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Injury, poisoning and procedural complications
Non-site specific injuries
|
26.2%
11/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
8.9%
4/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Psychiatric disorders
Depressive disorders
|
23.8%
10/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
22.2%
10/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue pain and discomfort
|
19.0%
8/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
20.0%
9/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Surgical and medical procedures
Analgesia supportive care
|
14.3%
6/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
11.1%
5/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
General disorders
General signs and symptoms
|
14.3%
6/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
11.1%
5/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
General disorders
Withdrawal and rebound effects
|
14.3%
6/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
8.9%
4/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Psychiatric disorders
Emotional and mood disturbances
|
11.9%
5/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Metabolism and nutrition disorders
General nutritional disorders
|
11.9%
5/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Infections and infestations
Infection
|
11.9%
5/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Metabolism and nutrition disorders
Appetite disorders
|
9.5%
4/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Injury, poisoning and procedural complications
Bone and joint injuries
|
9.5%
4/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
6.7%
3/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
4/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Gastrointestinal disorders
Nausea and vomiting symptoms
|
9.5%
4/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Psychiatric disorders
Sleep disorders
|
9.5%
4/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
11.1%
5/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Infections and infestations
Coronavirus infection
|
7.1%
3/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
11.1%
5/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Investigations
Imaging procedures
|
7.1%
3/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Nervous system disorders
Mental impairment (excluding dementia and memory loss)
|
7.1%
3/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion and inflammation
|
7.1%
3/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Nervous system disorders
Neurological signs and symptoms
|
7.1%
3/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
0.00%
0/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Surgical and medical procedures
Therapeutic procedures
|
7.1%
3/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
6.7%
3/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Infections and infestations
Urinary tract infection
|
7.1%
3/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
6.7%
3/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
2/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
6.7%
3/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
|
Surgical and medical procedures
Dental and gingival therapeutic procedures
|
0.00%
0/42 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
13.3%
6/45 • From enrollment until end of intervention, up to 24 weeks
Adverse events were systematically assessed at all study visits (Weeks 0, 4, 8, 12, 16, 20 and 24).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place