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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50DA009236 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Research Foundation for Mental Hygiene, Inc. | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The following study is designed to determine the analgesic efficacy of smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Oral THC (dronabinol) is known to have a slower onset and longer duration of action compared with smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and last longer than effects produced by smoked marijuana.
Laboratory animal studies have demonstrated the analgesic effects of drugs which act on the cannabinoid system, however, these effects have et to be clearly elucidated in humans. To better understand the potential clinical application of cannabinoids for pain management, the following study is designed to determine the analgesic efficacy of smoked marijuana (3.56% THC) and oral THC (20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Non-treatment seeking marijuana smokers will be recruited for a five-session study during which the analgesic, subjective, and physiologic effects of cannabinoids will be evaluated. Determining the efficacy of cannabinoids in an experimental model of pain will provide important endpoints (i.e., dose, route of administration, time course) or this effect to further investigate the potential role for clinical use of smoked marijuana and/or oral THC as analgesics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + inactive marijuana (0% THC) | Placebo Comparator | Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. |
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| Dronabinol 10 mg + Marijuana (0% THC) | Experimental | Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. |
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| Dronabinol 20 mg + Marijuana (0% THC) | Experimental | Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. |
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| Placebo + Marijuana (1.98% THC) | Experimental | Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order. |
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| Placebo + Marijuana (3.56% THC) | Experimental | Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo capsules | Drug | Placebo capsules |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Tolerance | Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion). | Within each session lasting approximately 5 minutes, for a total of five sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Haney, Ph.D | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23609132 | Background | Cooper ZD, Comer SD, Haney M. Comparison of the analgesic effects of dronabinol and smoked marijuana in daily marijuana smokers. Neuropsychopharmacology. 2013 Sep;38(10):1984-92. doi: 10.1038/npp.2013.97. Epub 2013 Apr 22. |
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Thirty-four participants were enrolled, and 30 completed. A total of 30 participants completed all 5 treatment combinations in randomized order.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Dronabinol + Marijuana | During each session, one capsule containing placebo or dronabinol (10 mg or 20 mg) was administered to the participant 45 min before marijuana was smoked (0, 1.98, or 3.56% THC marijuana). Only one active dose of marijuana or dronabinol was administered within a session. A within-subject design was used in which all participants received all strengths of dronabinol and marijuana. The order was randomized. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Placebo-controlled, double-blind
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| Inactive marijuana (0% THC) | Drug | Inactive marijuana cigarettes (0% THC) provided by NIDA |
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| Low dose Dronabinol | Drug | Dronabinol 10mg |
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| High dose Dronabinol | Drug | Dronabinol 20mg |
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| Low THC marijuana | Drug | marijuana cigarettes (1.98% THC) provided by NIDA |
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| High THC marijuana | Drug | Marijuana cigarettes (3.56% THC) provided by NIDA |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Number of Baseline Participants | 34 participants were enrolled, but only 30 participants completed. Out of the additional 4 volunteers, 1 discontinued for personal reasons and three were unreliable. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Pain Tolerance | Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion). | All participants who completed the study (N=30) were included in the final analysis. | Posted | Mean | Standard Error | seconds | Within each session lasting approximately 5 minutes, for a total of five sessions |
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Adverse events were documented pre- and post-treatment and 1 week after completion of the entire study.
Research staff routinely asked participants to report any adverse events occurring during study sessions and during outpatient washout periods.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + Marijuana (0% THC) | Adverse events recorded during Placebo (PBO) + Marijuana (0% THC) treatment | 0 | 34 | 0 | 34 | ||
| EG001 | Dronabinol 10 mg + Marijuana (0% THC) | Adverse events recorded during Dronabinol 10 mg + Marijuana (0% THC) treatment | 0 | 34 | 0 | 34 | ||
| EG002 | Dronabinol 20mg + Marijuana (0% THC) | Adverse events recorded during Dronabinol 20mg + Marijuana (0% THC) treatment | 0 | 34 | 0 | 34 | ||
| EG003 | Placebo + Marijuana (1.98% THC) | Adverse events recorded during placebo + Marijuana (1.98% THC) treatment | 0 | 34 | 0 | 34 | ||
| EG004 | Placebo + Marijuana (3.56% THC) | Adverse events recorded during Placebo + Marijuana (3.56% THC) treatment | 0 | 34 | 0 | 34 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ziva Cooper | New York State Psychiatric Institute | 646-774-6129 | zc2160@cumc.columbia.edu |
| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D010146 | Pain |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
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| D013759 | Dronabinol |
| ID | Term |
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| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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