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NCT04161144 · ClinicalTrials.gov registry record · Phase 2

Enhancing Self Regulation Among Smokers

A Phase 2 study, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT04161144: Completed Phase 2 study, sponsored by Medical University of South Carolina.

NCT04161144 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04161144, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study 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.

Primary Outcome

Patients are asked about craving level on a scale of 0-100, 0 is least amount of craving and 100 is highest amount of craving

Interventions

  • DRUG Placebo
  • DRUG sirolimus

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2018-10-01
Est. Completion 2019-12-20
Phase Phase 2

What the finished NCT04161144 record still lists

NCT04161144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04161144 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04161144 about?

NCT04161144 is a clinical study titled "Enhancing Self Regulation Among Smokers". 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) prev...

What is the current status of trial NCT04161144?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2018-10-01. Estimated completion is 2019-12-20.

What interventions are being tested in trial NCT04161144?

The interventions under investigation include: Placebo (DRUG), sirolimus (DRUG).

Who is sponsoring clinical trial NCT04161144?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04161144's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04161144, the US trial registry maintained by the National Library of Medicine. NCT04161144 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.