Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers

This study has been completed.

Sponsor:

Collaborators:

Research Foundation for Mental Hygiene, Inc.

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT00743119

First received: August 26, 2008

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 26, 2008

Last Updated Date

February 4, 2013

Start Date ^ICMJE

June 2008

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

analgesic response [ Time Frame: 7 hours ] [ Designated as safety issue: No ]

Cold water pressor task

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00743119 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

intoxication [ Time Frame: 7 hours ] [ Designated as safety issue: No ]

visual analog scales of cannabis intoxication

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers

Official Title ^ICMJE

Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers

Brief Summary

The purpose of this study is 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 (0. 198, 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. Both smoked marijuana and oral THC will produce dose- and time-dependent analgesic effects in the cold-pressor test. Oral THC 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 (0, 1.98, 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. 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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Pain
Mood

Intervention ^ICMJE

Drug: Oral THC
0, 10, and 20 mg

Other Name: marinol
Drug: Marijuana
0%, 1.98% and 3.56%

Other Name: cannabis

Study Arm (s)

Experimental: oral THC, marijuana

smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg)

Interventions:

Drug: Oral THC
Drug: Marijuana

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

21 Years to 45 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00743119

Other Study ID Numbers ^ICMJE

5603, 5P50DA009236

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

New York State Psychiatric Institute

Study Sponsor ^ICMJE

New York State Psychiatric Institute

Collaborators ^ICMJE

Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Margaret Haney, Ph.D

New York State Psychiatric Institute

Information Provided By

New York State Psychiatric Institute

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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