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Enhancing Self Regulation Among Smokers

NCT04161144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-03-09

Study results available
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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.

Conditions

  • Smoking Cessation
  • Smoking, Cigarette
  • Nicotine Dependence

Interventions

DRUG

sirolimus

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Michael Saladin, Ph.D. · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-12-20
Completion
2019-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04161144 on ClinicalTrials.gov