Gemfibrozil for Nicotine Smoking Cessation

Completed · Phase 2

Conditions studied: Smoking Cessation

In brief

This project will test whether gemfibrozil, a well-studied medication for high cholesterol, will help people stop smoking nicotine cigarette smoking. The study will also test whether gemfibrozil decrease cravings for cigarette and the desire to smoke.

Key facts

Study ID

NCT02638597

Run by

University of Texas Southwestern Medical Center

People needed

16

Starts

2015-02-01

Expected to finish

2016-12-23

Last updated by the study team

2019-02-01

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-64 years
• Meet DSM-5 criteria for tobacco use disorder based on cigarette use
• Desire to quit smoking
• Able to complete assessments and interview in English

You may not qualify if…

• Psychiatric co-morbidity posing safety risk, including current suicidality or psychosis as assessed on clinical interview
• Concurrent use of a statin medication (HMG-CoA reductase inhibitor),anticoagulant, or repaglinide
• Concurrent use of any FDA-approved medication for smoking cessation
• Use of any form of tobacco or nicotine (including vaporizer) other than cigarette smoking
• Any DSM-5 substance use disorder other than nicotine use disorder
• History of intolerance to any fibrate medication
• History of gallbladder disease and cholestectomy has not been performed
• Baseline liver function tests > twice the upper limit of normal
• Severe impairment of renal function (baseline serum creatinine ≥ 2 mg/dL)
• Currently pregnant or nursing

Where it is running

• Parkland Memorial Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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