CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 8 enrolled
Drug / intervention
Progesterone +1 moredrug
Likely dose
Placebo 200mgfrom 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/NCT03430050
NCT03430050Early Ph 1Completed

Progesterone for the Treatment of Cannabis Withdrawal

Medical University of South Carolina·interventional·Posted Feb 12, 2018·Updated May 22, 2019

In Brief

A Early Phase 1 clinical trial evaluating Progesterone and Placebo for Cannabis Use Disorder and Cannabis Withdrawal. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Sex and gender differences in behavioral, biological, and clinical correlates of substance use disorders are myriad, yet there exists a dearth of gender-informed treatment options. Ovarian hormones have been identified as potential mechanisms of these disparities , and recent clinical trials have begun to examine their utility as possible pharmacotherapeutic agents. The ovarian hormone progesterone has shown promise as a treatment for female cocaine and nicotine users, but has not yet been tested for cannabis. Gender differences in cannabis withdrawal, which is associated with relapse, are pronounced and several studies report more severe and impairing withdrawal symptoms in women compared to men. Developing pharmacological interventions for cannabis withdrawal remains an important priority given the significant cognitive, psychiatric, and physical consequences of heavy cannabis use.

Study Details

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

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedFeb 12, 2018
Enrollment StartOct 16, 2017
Primary CompletionApr 4, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.4 years ago

Interventions

Progesteronedrug

Progesterone capsule

Placebodrug

Placebo capsule. Manufactured to mimic progesterone 200mg capsule.