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NCT03593538 · ClinicalTrials.gov registry record · Phase 2

Effects of Metformin During Nicotine Withdrawal

A Phase 2 study, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target

NCT03593538: Completed Phase 2 study, sponsored by University of Pennsylvania.

NCT03593538 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03593538, a Phase 2 study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study Summary

The purpose of this study is to test the effects of a medication called metformin (Glucophage®) on smoking behavior. This medication is FDA-approved for treatment of type-2 diabetes. It is being used for research purposes in this study. Participants will be randomized to one of 3 treatment groups: low dose of metformin, high dose of metformin, or placebo.

Primary Outcome

Self-reported mood on the Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format measure that assesses Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset). The minimum value for each subscale is 10 and the maximum value is 50. Higher scores indicate greater positive or negative affect.

Interventions

  • DRUG Placebo
  • DRUG Metformin

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2016-04-01
Est. Completion 2020-03-13
Phase Phase 2
University of Pennsylvania

1,423 total trials

What the finished NCT03593538 record still lists

NCT03593538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

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

NCT03593538 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03593538 about?

NCT03593538 is a clinical study titled "Effects of Metformin During Nicotine Withdrawal". The purpose of this study is to test the effects of a medication called metformin (Glucophage®) on smoking behavior. This medication is FDA-approved for treatment of type-2 diabetes. It is being used for research purposes in this study. Participants will be randomized to one of 3 treatment groups: l...

What is the current status of trial NCT03593538?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2016-04-01. Estimated completion is 2020-03-13.

What interventions are being tested in trial NCT03593538?

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

Who is sponsoring clinical trial NCT03593538?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03593538's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 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 NCT03593538, the US trial registry maintained by the National Library of Medicine. NCT03593538 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.