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

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ClinicalTrials.gov Identifier: NCT00743119
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Conditions Pain Threshold
Mood
Interventions Drug: Placebo capsules
Drug: Inactive marijuana (0% THC)
Drug: Low dose Dronabinol
Drug: High dose Dronabinol
Drug: Low THC marijuana
Drug: High THC marijuana
Enrollment 34
Recruitment Details  
Pre-assignment Details Thirty-four participants were enrolled, and 30 completed. A total of 30 participants completed all 5 treatment combinations in randomized order.
Arm/Group Title Placebo/Dronabinol + Marijuana
Hide Arm/Group Description During each session, one capsule containing placebo or dronabinol (10 mg or 20 mg) was administered to the participant 45 min before marijuana was smoked (0, 1.98, or 3.56% THC marijuana). Only one active dose of marijuana or dronabinol was administered within a session. A within-subject design was used in which all participants received all strengths of dronabinol and marijuana. The order was randomized.
Period Title: Overall Study
Started 34
Completed 30
Not Completed 4
Reason Not Completed
unreliable             3
Withdrawal by Subject             1
Arm/Group Title Overall Number of Baseline Participants
Hide Arm/Group Description 34 participants were enrolled, but only 30 participants completed. Out of the additional 4 volunteers, 1 discontinued for personal reasons and three were unreliable.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
15
  50.0%
Male
15
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
 100.0%
1.Primary Outcome
Title Pain Tolerance
Hide Description 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).
Time Frame Within each session lasting approximately 5 minutes, for a total of five sessions
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study (N=30) were included in the final analysis.
Arm/Group Title High Dose Dronabinol + Inactive Marijuana Low Dose Dronabinol + Inactive Marijuana Placebo + Low THC Marijuana Placebo + High THC Marijuana Placebo + Inactive Marijuana 0% THC
Hide Arm/Group Description:
Dronabinol 20 mg + inactive marijuana (0%THC)
10mg Dronabinol + inactive Marijuana (0% THC)
Placebo + Marijuana (1.98% THC)
Placebo + high dose Marijuana (3.56% THC)
Placebo + inactive marijuana (0% THC)
Overall Number of Participants Analyzed 30 30 30 30 30
Mean (Standard Error)
Unit of Measure: seconds
6.1  (4.4) 2.8  (2.9) 4.9  (3.4) 1.5  (1.4) 1.5  (1.4)
Time Frame Adverse events were documented pre- and post-treatment and 1 week after completion of the entire study.
Adverse Event Reporting Description Research staff routinely asked participants to report any adverse events occurring during study sessions and during outpatient washout periods.
 
Arm/Group Title Placebo + Marijuana (0% THC) Dronabinol 10 mg + Marijuana (0% THC) Dronabinol 20mg + Marijuana (0% THC) Placebo + Marijuana (1.98% THC) Placebo + Marijuana (3.56% THC)
Hide Arm/Group Description Adverse events recorded during Placebo (PBO) + Marijuana (0% THC) treatment Adverse events recorded during Dronabinol 10 mg + Marijuana (0% THC) treatment Adverse events recorded during Dronabinol 20mg + Marijuana (0% THC) treatment Adverse events recorded during placebo + Marijuana (1.98% THC) treatment Adverse events recorded during Placebo + Marijuana (3.56% THC) treatment
All-Cause Mortality
Placebo + Marijuana (0% THC) Dronabinol 10 mg + Marijuana (0% THC) Dronabinol 20mg + Marijuana (0% THC) Placebo + Marijuana (1.98% THC) Placebo + Marijuana (3.56% THC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + Marijuana (0% THC) Dronabinol 10 mg + Marijuana (0% THC) Dronabinol 20mg + Marijuana (0% THC) Placebo + Marijuana (1.98% THC) Placebo + Marijuana (3.56% THC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%)   0/34 (0.00%)   0/34 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo + Marijuana (0% THC) Dronabinol 10 mg + Marijuana (0% THC) Dronabinol 20mg + Marijuana (0% THC) Placebo + Marijuana (1.98% THC) Placebo + Marijuana (3.56% THC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%)   0/34 (0.00%)   0/34 (0.00%)   0/34 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ziva Cooper
Organization: New York State Psychiatric Institute
Phone: 646-774-6129
EMail: zc2160@cumc.columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743119     History of Changes
Other Study ID Numbers: 5603
5P50DA009236 ( U.S. NIH Grant/Contract )
First Submitted: August 26, 2008
First Posted: August 28, 2008
Results First Submitted: October 20, 2016
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017