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

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.

Conditions

• Pain Threshold
• Mood

Interventions

DRUG

Placebo capsules

Placebo capsules

DRUG

Inactive marijuana (0% THC)

Inactive marijuana cigarettes (0% THC) provided by NIDA

DRUG

Low dose Dronabinol

Dronabinol 10mg

DRUG

High dose Dronabinol

Dronabinol 20mg

DRUG

Low THC marijuana

marijuana cigarettes (1.98% THC) provided by NIDA

DRUG

High THC marijuana

Marijuana cigarettes (3.56% THC) provided by NIDA

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• New York State Psychiatric Institute

  lead OTHER

Principal Investigators

• Margaret Haney, Ph.D · New York State Psychiatric Institute

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2009-10-31

Completion

2013-05-31

FDA Drug

Yes

Countries

• United States

Study Locations