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Pregnenolone and Marijuana Dependence

NCT02439814 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-06-18

Study results available
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Summary

The cannabinoid delta 9-tetrahydrocannabinol (THC) is the primary psychoactive component of marijuana. THC is believed to be a significant factor in the addictive potential associated with marijuana use. In addition, attenuated levels of endogenous endocannabinoids have been found in alcohol-dependent individuals as compared to social drinkers, suggesting that changes in the sensitivity of the endogenous endocannabinoid system play a role in the transition from recreational drug use to substance use disorders. Thus, pharmacotherapies that target the cannabinoid system may be effective strategies for reducing marijuana use and dependence. Recent preclinical data demonstrate that the neurosteroid pregnenolone (PREG) inhibits THC activation of cannabinoid receptors and decreases symptoms of marijuana intoxication. In addition, other studies show that PREG inhibits drug-seeking behavior. This pilot study will provide important preliminary data on the effect of an acute dose of PREG on cue-related craving in individuals with cannabis use disorder.

Conditions

  • Marijuana Dependence

Interventions

DRUG

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

OTHER

Placebo

Inactive comparator

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Aimee McRae-Clark, PharmD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02439814 on ClinicalTrials.gov