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

NCT00743119 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 56035P50DA009236
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Threshold; Mood

Keywords

oral thc; cannabis; pain; analgesic effects; dronabinol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

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.

Drug: Placebo capsules; Drug: Inactive marijuana (0% THC)

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.

Drug: Inactive marijuana (0% THC); Drug: Low dose Dronabinol

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.

Drug: Inactive marijuana (0% THC); Drug: High dose Dronabinol

Placebo + Marijuana (1.98% THC)

EXPERIMENTAL

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

Drug: Placebo capsules; Drug: Low THC marijuana

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.

Drug: Placebo capsules; Drug: High THC marijuana

Interventions

Placebo capsules DRUG

Placebo capsules

Placebo + Marijuana (1.98% THC); Placebo + Marijuana (3.56% THC); Placebo + inactive marijuana (0% THC)

Inactive marijuana (0% THC) DRUG

Inactive marijuana cigarettes (0% THC) provided by NIDA

Dronabinol 10 mg + Marijuana (0% THC); Dronabinol 20 mg + Marijuana (0% THC); Placebo + inactive marijuana (0% THC)

Low dose Dronabinol DRUG

Dronabinol 10mg

Dronabinol 10 mg + Marijuana (0% THC)

High dose Dronabinol DRUG

Dronabinol 20mg

Dronabinol 20 mg + Marijuana (0% THC)

Low THC marijuana DRUG

marijuana cigarettes (1.98% THC) provided by NIDA

Placebo + Marijuana (1.98% THC)

High THC marijuana DRUG

Marijuana cigarettes (3.56% THC) provided by NIDA

Placebo + Marijuana (3.56% THC)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Research Foundation for Mental Hygiene, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 23609132 BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse; Pain

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Ziva Cooper
• Organization: New York State Psychiatric Institute

zc2160@cumc.columbia.edu

646-774-6129

Study Officials

• Margaret Haney, Ph.D

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo-controlled, double-blind
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: May 1, 2013
• Last Updated: December 11, 2017
• Results First Posted: December 11, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)