CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
sirolimus +1 moredrug
Likely dose
sirolimus 5mgfrom 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/NCT04161144
NCT04161144Phase 2Completed

Enhancing Self-regulation by Altering Memories That Increase Risk of Relapse Among Smokers: A Translational Clinical Neuroscience Study of a Novel Medication

Medical University of South Carolina·interventional·Posted Nov 13, 2019·Updated Mar 9, 2021

In Brief

A Phase 2 clinical trial evaluating sirolimus and Placebo for Smoking Cessation and 2 related conditions. Completed, enrolled 22 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 smoking cues in individuals with nicotine dependence. 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 for smoking cessation. The use of rapamycin (sirolimus) in this study is investigational, meaning that the study medication is not a proven treatment for nicotine dependence, however this study will examine the medication's use as a potential future treatment for nicotine dependence.

Study Details

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

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 13, 2019
Enrollment StartOct 1, 2018
Primary CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.6 years ago

Interventions

sirolimusdrug

Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.

Placebodrug

Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.