NCT03732248

Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alcohol Use Disorder
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Rapamycin	Immunosuppressive drug
DRUG	Placebo	Inert drug

Timeline

• Start date: 2018-07-12
• Primary completion: 2019-12-20
• Completion: 2020-01-20
• First posted: 2018-11-06
• Last updated: 2021-01-27
• Results posted: 2021-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study