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

NCT ID: NCT00743119

Last Updated: 2017-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Threshold Mood

Keywords

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oral thc cannabis pain analgesic effects dronabinol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Placebo-controlled, double-blind

Study Groups

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Placebo + inactive marijuana (0% THC)

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

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type DRUG

Placebo capsules

Inactive marijuana (0% THC)

Intervention Type DRUG

Inactive marijuana cigarettes (0% THC) provided by NIDA

Dronabinol 10 mg + Marijuana (0% THC)

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

Group Type EXPERIMENTAL

Inactive marijuana (0% THC)

Intervention Type DRUG

Inactive marijuana cigarettes (0% THC) provided by NIDA

Low dose Dronabinol

Intervention Type DRUG

Dronabinol 10mg

Dronabinol 20 mg + Marijuana (0% THC)

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

Group Type EXPERIMENTAL

Inactive marijuana (0% THC)

Intervention Type DRUG

Inactive marijuana cigarettes (0% THC) provided by NIDA

High dose Dronabinol

Intervention Type DRUG

Dronabinol 20mg

Placebo + Marijuana (1.98% THC)

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

Group Type EXPERIMENTAL

Placebo capsules

Intervention Type DRUG

Placebo capsules

Low THC marijuana

Intervention Type DRUG

marijuana cigarettes (1.98% THC) provided by NIDA

Placebo + Marijuana (3.56% THC)

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

Group Type EXPERIMENTAL

Placebo capsules

Intervention Type DRUG

Placebo capsules

High THC marijuana

Intervention Type DRUG

Marijuana cigarettes (3.56% THC) provided by NIDA

Interventions

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Placebo capsules

Placebo capsules

Intervention Type DRUG

Inactive marijuana (0% THC)

Inactive marijuana cigarettes (0% THC) provided by NIDA

Intervention Type DRUG

Low dose Dronabinol

Dronabinol 10mg

Intervention Type DRUG

High dose Dronabinol

Dronabinol 20mg

Intervention Type DRUG

Low THC marijuana

marijuana cigarettes (1.98% THC) provided by NIDA

Intervention Type DRUG

High THC marijuana

Marijuana cigarettes (3.56% THC) provided by NIDA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret Haney, Ph.D

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23609132 (View on PubMed)

Other Identifiers

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5P50DA009236

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5603

Identifier Type: -

Identifier Source: org_study_id