CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Pregnenolone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02439814
NCT02439814Phase 2Completed

Effect of Pregnenolone on Cue-reactivity in Marijuana-dependent Individuals

Medical University of South Carolina·interventional·Posted May 12, 2015·Updated Jun 18, 2018

In Brief

A Phase 2 clinical trial evaluating Pregnenolone and Placebo for Marijuana Dependence. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 12, 2015
Enrollment StartJun 1, 2015
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.1 years ago

Interventions

Pregnenolonedrug

Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication

Placeboother

Inactive comparator