Impact of Repeatedly-Administered THC-cannabis on Experimental Pain and Abuse Liability in Humans
NCT ID: NCT04596644
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
16 participants
INTERVENTIONAL
2021-08-01
2025-10-31
Brief Summary
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The proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory study (N = 20 healthy cannabis users; 10 men, 10 women) will address three important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) Does tolerance develop to repeated, daily smoked cannabis administration on measures of experimental pain and abuse liability; 2) If so, is tolerance reversed during the 7 days of abstinence from active-THC cannabis; 3) Does abrupt abstinence from active cannabis increase experimental pain sensitivity, i.e. hyperalgesia, relative to baseline, and do these effects parallel measures of cannabis withdrawal such as disrupted mood and sleep?
Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS). Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Dose A: Standardization Phase
On the first full inpatient day (Day 1), participants smoke one specified strength (Dose A; 75% of two 6.58% cannabis cigarettes) of cannabis at three timepoints.
Active Cannabis
6.58% THC + \<0.01% CBD cannabis (in one cigarette)
Dose B: Placebo Phase
On Days 2-8, participants smoke a second strength (Dose B; 75% of two \< 0.01%THC:CBD cannabis cigarettes) of cannabis will be administered 3x/day.
Placebo Cannabis
\<0.01% THC:CBD cannabis.
Dose A: Active Phase
On Days 9-15, cannabis Dose A will be administered again (75% of two 6.58% cannabis cigarettes) at three timepoints each day.
Active Cannabis
6.58% THC + \<0.01% CBD cannabis (in one cigarette)
Interventions
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Active Cannabis
6.58% THC + \<0.01% CBD cannabis (in one cigarette)
Placebo Cannabis
\<0.01% THC:CBD cannabis.
Eligibility Criteria
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Inclusion Criteria
* Current cannabis user
* Able to perform all study procedures
Exclusion Criteria
* If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process reveal any significant illness that the study physician deems contraindicated for study participation
* Insensitivity to the cold-water stimulus of the Cold Pressor Test or the heat stimulus of Quantitative Sensory Testing
21 Years
60 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Caroline A. Arout, Ph.D.
Assistant Professor of Clinical Neurobiology (in Psychiatry)
Locations
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New York State Psychiatric Institute
New York, New York, United States
Countries
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Other Identifiers
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8058
Identifier Type: -
Identifier Source: org_study_id
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