CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Rapamycin +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/NCT03732248
NCT03732248Phase 1Completed

Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders: A Translational Clinical Neuroscience Pilot Investigation of a Novel Pharmacological Agent

Medical University of South Carolina·interventional·Posted Nov 6, 2018·Updated Jan 27, 2021

In Brief

A Phase 1 clinical trial evaluating Rapamycin and Placebo for Alcohol Use Disorder and Alcohol Dependence. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the effects of rapamycin (sirolimus) versus a placebo, an inactive substance, on responses to alcohol cues in individuals with alcohol use disorder. Rapamycin (sirolimus) is a FDA-approved antibiotic and immunosuppressive drug that is currently used to (a) prevent organ transplant recipients from rejecting their transplants (b) treat cardiovascular diseases, and (c) treat some forms of cancer. Rapamycin (sirolimus) is not FDA-approved to treat alcohol use disorder. The use of rapamycin (sirolimus) in this study is investigational, meaning that the study medication is not a proven treatment for alcohol use disorder. The study will examine the medication's use as a potential treatment for alcohol use disorder, as well as how safe and tolerable it is to take.

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 6, 2018
Enrollment StartJul 12, 2018
Primary CompletionDec 20, 2019
Study CompletionJan 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.7 years ago

Interventions

Rapamycindrug

Immunosuppressive drug

Placebodrug

Inert drug