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

Phase 2

Completed

• Conditions: Mood; Pain Threshold
• Interventions: Drug: Inactive marijuana (0% THC); Drug: Placebo capsules; Drug: Low THC marijuana; Drug: Low dose Dronabinol; Drug: High THC marijuana; Drug: High dose Dronabinol

• Registration Number: NCT00743119
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-28
• Primary Completion: 2009-10
• Study Completion: 2013-05
• Results First Submitted: 2016-10-20
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-07
• Last Update Submitted: 2017-11-07
• Results First Posted: 2017-12-11
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dronabinol 20 mg + Marijuana (0% THC)	Inactive marijuana (0% THC)	Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
Placebo + Marijuana (1.98% THC)	Placebo capsules	Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order.
Placebo + Marijuana (1.98% THC)	Low THC marijuana	Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order.
Placebo + inactive marijuana (0% THC)	Placebo capsules	Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
Dronabinol 10 mg + Marijuana (0% THC)	Low dose Dronabinol	Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
Placebo + Marijuana (3.56% THC)	High THC marijuana	Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order.
Placebo + inactive marijuana (0% THC)	Inactive marijuana (0% THC)	Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
Dronabinol 10 mg + Marijuana (0% THC)	Inactive marijuana (0% THC)	Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
Dronabinol 20 mg + Marijuana (0% THC)	High dose Dronabinol	Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
Placebo + Marijuana (3.56% THC)	Placebo capsules	Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order.

Primary Outcome Measures

Name	Time	Method
Pain Tolerance	Within each session lasting approximately 5 minutes, for a total of five sessions	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).

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States