Trial Outcomes & Findings for Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana (NCT NCT00743145)

Last Updated: 2018-09-14

Results Overview

Subjective ratings of marijuana's quality and effect ('Strength', 'Good Effect', 'High', 'Stimulation') and craving ('Want Marijuana') as a function of active puffs and naltrexone, using a visual analogue scale with a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to indicate how they felt at that particular moment. Higher ratings indicate more agreement with the statement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.

Results posted on

2018-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo, Naltrexone, Marijuana A total of 23 participants enrolled but only 19 completed. All patients participated in all conditions; they were randomized to placebo or naltrexone treatment in a counterbalanced fashion, and underwent all smoking conditions in separate, counterbalanced sessions.
Overall Study STARTED	23
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo, Naltrexone, Marijuana A total of 23 participants enrolled but only 19 completed. All patients participated in all conditions; they were randomized to placebo or naltrexone treatment in a counterbalanced fashion, and underwent all smoking conditions in separate, counterbalanced sessions.
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	2
Overall Study Pregnancy	1

Baseline Characteristics

Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo, Naltrexone, Marijuana n=19 Participants During each of the 8 outpatient sessions, participants smoked a total of 6 puffs from 3 marijuana cigarettes (2 puffs from each cigarette). Marijuana administration occurred 45 minutes after capsule administration. The number of active versus inactive cigarettes smoked during each session varied, according to active puff conditions (i.e., 0 puffs = 3 inactive cigarettes; 2 puffs = 1 active + 2 inactive cigarette; 4 puffs = 2 active + 1 inactive cigarette; 6 puffs = 3 active + 0 inactive cigarette). Cigarettes were color coded, indicating the order in which they were to be smoked and active cigarettes were always smoked before inactive. A within-subject design was used in which all participants were exposed to each of the puff conditions in combination with naltrexone or placebo. The order of naltrexone dosing and puff condition was randomized within the session and across participants.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27.0 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.