Gemfibrozil for Nicotine Smoking Cessation

• Status: Completed
• Trial end date: 2016-12-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Gemfibrozil; Nicotine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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