Trial Outcomes & Findings for Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers (NCT NCT00743119)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Within each session lasting approximately 5 minutes, for a total of five sessions

Results posted on

2017-12-11

Participant Flow

Thirty-four participants were enrolled, and 30 completed. A total of 30 participants completed all 5 treatment combinations in randomized order.

Participant milestones

Participant milestones
Measure	Placebo/Dronabinol + Marijuana 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.
Overall Study STARTED	34
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/Dronabinol + Marijuana 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.
Overall Study unreliable	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Number of Baseline Participants n=30 Participants 34 participants were enrolled, but only 30 participants completed. Out of the additional 4 volunteers, 1 discontinued for personal reasons and three were unreliable.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within each session lasting approximately 5 minutes, for a total of five sessions

Population: All participants who completed the study (N=30) were included in the final analysis.

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).