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

Tracking Information
First Submitted Date ICMJE	August 26, 2008
First Posted Date ICMJE	August 28, 2008
Results First Submitted Date	October 20, 2016
Results First Posted Date	December 11, 2017
Last Update Posted Date	December 11, 2017
Study Start Date ICMJE	June 2008
Actual Primary Completion Date	October 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 7, 2017)	Pain Tolerance [ Time Frame: 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).
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	Not Provided
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	Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
Official Title ICMJE	Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
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 Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Masking Description: Placebo-controlled, double-blind Primary Purpose: Other
Condition ICMJE	Pain Threshold; Mood
Intervention ICMJE	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
Study Arms	Placebo Comparator: Placebo + inactive marijuana (0% THC) Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. Interventions: Drug: Placebo capsules Drug: Inactive marijuana (0% THC); Experimental: Dronabinol 10 mg + Marijuana (0% THC) Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. Interventions: Drug: Inactive marijuana (0% THC) Drug: Low dose Dronabinol; Experimental: Dronabinol 20 mg + Marijuana (0% THC) Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. Interventions: Drug: Inactive marijuana (0% THC) Drug: High dose Dronabinol; Experimental: Placebo + Marijuana (1.98% THC) Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order. Interventions: Drug: Placebo capsules Drug: Low THC marijuana; Experimental: Placebo + Marijuana (3.56% THC) Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order. Interventions: Drug: Placebo capsules Drug: High THC marijuana
Publications *	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.
* 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
Actual Enrollment ICMJE; (submitted: November 7, 2017)	34
Original Estimated Enrollment ICMJE; (submitted: August 26, 2008)	48
Actual Study Completion Date	May 2013
Actual 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
Sex/Gender	Sexes Eligible for Study: 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 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
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
PRS Account	New York State Psychiatric Institute
Verification Date	November 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP