Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers

New York State Psychiatric Institute

Status and phase: Completed; Phase 2

Conditions: Mood; Pain Threshold

Treatments: Drug: Low dose Dronabinol; Drug: High dose Dronabinol; Drug: Low THC marijuana; Drug: Inactive marijuana (0% THC); Drug: Placebo capsules; Drug: High THC marijuana

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00743119

5P50DA009236 (U.S. NIH Grant/Contract)

5603

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults between the ages of 21-45
• Current marijuana use
• Able to perform study procedures
• Women practicing an effective form of birth control

Exclusion criteria

• Female subjects who are currently pregnant or breastfeeding
• Current,repeated illicit drug use other than marijuana
• Presence of significant medical illness
• History of heart disease
• Request for drug treatment
• Current parole or probation
• Recent history of significant violent behavior

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 5 patient groups, including a placebo group

Placebo + inactive marijuana (0% THC)

Placebo Comparator group

Description:

Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.

Treatment:

Drug: Placebo capsules

Drug: Inactive marijuana (0% THC)

Dronabinol 10 mg + Marijuana (0% THC)

Experimental group

Description:

Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.

Treatment:

Drug: Low dose Dronabinol

Drug: Inactive marijuana (0% THC)

Dronabinol 20 mg + Marijuana (0% THC)

Experimental group

Description:

Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.

Treatment:

Drug: Inactive marijuana (0% THC)

Drug: High dose Dronabinol

Placebo + Marijuana (1.98% THC)

Experimental group

Description:

Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order.

Treatment:

Drug: Placebo capsules

Drug: Low THC marijuana

Placebo + Marijuana (3.56% THC)

Experimental group

Description:

Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order.

Treatment:

Drug: Placebo capsules

Drug: High THC marijuana