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Effects of Metformin During Nicotine Withdrawal — MEP  

Smoking Clinical Trial

Official title:
Effects of Metformin on Mood and Cognition During Nicotine Withdrawal

Clinical Trial 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.

Clinical Trial Description

There is a need for novel approaches to optimize smoking cessation treatment to help more smokers quit. Mood disturbance and cognitive deficits during nicotine withdrawal may be important treatment targets given their association with smoking relapse. In addition, factors such as HIV-1 infection may exacerbate abstinence effects on mood and cognitive deficits and thus should be measured and controlled for. The investigators hypothesize that the FDA-approved medication, metformin, will attenuate withdrawal-related mood disturbance and cognitive deficits, controlling for HIV status. Using a well-validated abstinence challenge paradigm, the investigators propose a placebo-controlled double-blind parallel arm study with one between-subjects factor of medication (low dose: 500 mg, high dose: 1500 mg, and placebo). Non-treatment seeking smokers (HIV-: n=54; 18 per group) will complete this 23 day study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03593538
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase Phase 2
Start date April 1, 2016
Completion date March 13, 2020
View Details
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