Trial Outcomes & Findings for Pregnenolone and Marijuana Dependence (NCT NCT02439814)

NCT ID: NCT02439814

Last Updated: 2018-06-18

Results Overview

Change in craving from post medication administration to post active cue. Scale of 1-7 with 7 meaning the craving is most severe.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 12:40 to 14:45 (post med administration, post Marijuana cue
• Results posted on: 2018-06-18

Participant Flow

Subjects were primarily recruited through media advertisements and word of mouth.

Participant milestones

Measure	Pregnenolone Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication	Placebo Placebo: Inactive comparator
Overall Study STARTED	11	10
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pregnenolone and Marijuana Dependence

Baseline characteristics by cohort

Measure	Pregnenolone n=11 Participants Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication	Placebo n=10 Participants Placebo: Inactive comparator	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.4 Years n=5 Participants	25.6 Years n=7 Participants	26 Years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 12:40 to 14:45 (post med administration, post Marijuana cue

Change in craving from post medication administration to post active cue. Scale of 1-7 with 7 meaning the craving is most severe.

Outcome measures

Measure	Pregnenolone n=11 Participants Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication	Placebo n=10 Participants Placebo: Inactive comparator
Subjective Rating of Marijuana Craving on 1-7 Likert Scale	1.64 units on a scale Standard Deviation 1.71	0.80 units on a scale Standard Deviation 1.79

Adverse Events

Pregnenolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. McRae-Clark

Medical University of South Carolina

Phone: 843-792-5216

Email: mcraeal@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place