Trial Outcomes & Findings for Repeated Cannabis Administration on Experimental Pain and Abuse Liability (NCT NCT04576507)
NCT ID: NCT04576507
Last Updated: 2025-08-08
Results Overview
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points reported here represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15). Other timepoints are not reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 15 days
Results posted on
2025-08-08
Participant Flow
Participants were recruited between June 2021 and June 2023. Eligible participants were recruited from the New York, NY area and occurred through advertisements in local newspapers, online through Craigslist, RecruitMe, and by word of mouth.
There were no significant events in the study post-enrollment and/or prior to participants beginning study procedures.
Participant milestones
| Measure |
Dose A - Dose B - Dose A
On the first full inpatient day (Day 1), participants smoked one specified strength (Dose A; active cannabis, 2.98% THC, 4.91% CBD) of cannabis. Days 2-8 comprised Phase 1, in which a second strength (Dose B; placebo cannabis, \<0.01% THC, CBD) of cannabis was administered 3x/day. The next 7 days (Day 9-15) comprised Phase 2, in which cannabis Dose A (active cannabis, 2.98% THC, 4.91% CBD) was administered again, at the same 3 daily time points. All participants underwent this same allocation.
Cannabis: Investigates two strengths of cannabis.
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|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Dose A - Dose B - Dose A
On the first full inpatient day (Day 1), participants smoked one specified strength (Dose A; active cannabis, 2.98% THC, 4.91% CBD) of cannabis. Days 2-8 comprised Phase 1, in which a second strength (Dose B; placebo cannabis, \<0.01% THC, CBD) of cannabis was administered 3x/day. The next 7 days (Day 9-15) comprised Phase 2, in which cannabis Dose A (active cannabis, 2.98% THC, 4.91% CBD) was administered again, at the same 3 daily time points. All participants underwent this same allocation.
Cannabis: Investigates two strengths of cannabis.
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|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Repeated Cannabis Administration on Experimental Pain and Abuse Liability
Baseline characteristics by cohort
| Measure |
Dose A - Dose B - Dose A
n=5 Participants
On the first full inpatient day (Day 1), participants smoked one specified strength (Dose A; active cannabis, 2.98% THC, 4.91% CBD) of cannabis. Days 2-8 comprised Phase 1, in which a second strength (Dose B; placebo cannabis, \<0.01% THC, CBD) of cannabis was administered 3x/day. The next 7 days (Day 9-15) comprised Phase 2, in which cannabis Dose A (active cannabis, 2.98% THC, 4.91% CBD) was administered again, at the same 3 daily time points. All participants underwent this same allocation.
Cannabis: Investigates two strengths of cannabis.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 15 daysPopulation: Data represents CPT Pain Tolerance for study completers (n=5) across the 15-day testing period. This is a repeated measures design, meaning that all 5 participants contributed to each timepoint.
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points reported here represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15). Other timepoints are not reported.
Outcome measures
| Measure |
CPT Pain Tolerance: Day 2
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 5
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 8
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 9
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 12
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 15
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
Day 15 Cannabis Rating Form: "High"
Participants rate the "high" experienced as a result of cannabis administration on a 100mm visual analog scale. Data points represent Percent Change from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15) Repeats at days 1, 2, 5, 8, 9, 12, and 15.
|
|---|---|---|---|---|---|---|---|
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Change in Cold Pressor Test (CPT) Latency
|
21.40 percent change from Day 1 baseline
Standard Error 24.22
|
10.94 percent change from Day 1 baseline
Standard Error 18.81
|
2.07 percent change from Day 1 baseline
Standard Error 5.84
|
15.17 percent change from Day 1 baseline
Standard Error 16.97
|
20.06 percent change from Day 1 baseline
Standard Error 25.07
|
30.16 percent change from Day 1 baseline
Standard Error 28.67
|
—
|
SECONDARY outcome
Timeframe: Up to 15 daysPopulation: Data represents mean ratings for "high" on a 0-100mm visual analog scale, where 0 represents no "high" and 100 represents the maximum amount of "high" for study completers (n=5) across the 15-day testing period. This is a repeated measures design, meaning that all 5 participants contributed to each timepoint.
Participants rate the "high" experienced as a result of cannabis administration on a 100mm visual analog scale. Data points represent Percent Change from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15) Repeats at days 1, 2, 5, 8, 9, 12, and 15.
Outcome measures
| Measure |
CPT Pain Tolerance: Day 2
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 5
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 8
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 9
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 12
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
CPT Pain Tolerance: Day 15
n=5 Participants
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes.
Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15).
|
Day 15 Cannabis Rating Form: "High"
n=5 Participants
Participants rate the "high" experienced as a result of cannabis administration on a 100mm visual analog scale. Data points represent Percent Change from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15) Repeats at days 1, 2, 5, 8, 9, 12, and 15.
|
|---|---|---|---|---|---|---|---|
|
Change in Cannabis Rating Form (CRF) Ratings
|
14.60 score on a scale
Standard Error 7.53
|
9.6 score on a scale
Standard Error 7.756
|
17.60 score on a scale
Standard Error 12.66
|
11.20 score on a scale
Standard Error 8.16
|
30.80 score on a scale
Standard Error 10.29
|
42.00 score on a scale
Standard Error 18.20
|
41.40 score on a scale
Standard Error 15.84
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=10 participants at risk
Data on potential adverse events were collected throughout the duration of the study (06/2021 - 06/2023).
|
|---|---|
|
Cardiac disorders
High blood pressure
|
10.0%
1/10 • Number of events 1 • Information on adverse events was collected continuously for the duration of study participation for each participant, which was approximately 1 month (screening through study completion). All participants received the same order of drug administration and as such, are reported under one condition.
Drug effects as a result of cannabis administration were expected, and not considered adverse events at the time.
|
|
Gastrointestinal disorders
Acid reflux
|
10.0%
1/10 • Number of events 1 • Information on adverse events was collected continuously for the duration of study participation for each participant, which was approximately 1 month (screening through study completion). All participants received the same order of drug administration and as such, are reported under one condition.
Drug effects as a result of cannabis administration were expected, and not considered adverse events at the time.
|
Additional Information
Caroline A. Arout, Ph.D.
New York State Psychiatric Institute
Phone: 646-774-6167
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place