Gemfibrozil for Nicotine Smoking Cessation

Phase 2

Completed

Conditions: Smoking Cessation

Interventions: Drug: Gemfibrozil
Behavioral: smoking cessation counseling

Registration Number: NCT02638597

Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description: This is a pilot clinical trial examining the feasibility and efficacy of gemfibrozil treatment for smoking cessation. Adults with a desire to quit nicotine cigarette smoking will be recruited. Eligible participants will be randomly divided into two groups: those who receive gemfibrozil and waitlist controls. Screening will be conducted with a brief phone screen followed by a longer screening visit for those who qualify. During the screening visit, all study participants will provide demographic information and will be interviewed regarding smoking history. Procedures performed during the screening visit include a blood draw, urine pregnancy test, physical exam, clinical psychiatric interview, and measurement of exhaled carbon monoxide (CO). At baseline, participants will complete the Heavy Smoking Index (HSI) and the Brief Questionnaire of Smoking Urges (QSU-Brief). Participants will also complete the Quick Inventory of Depressive Symptoms-Self Rated (QIDS-SR) to assess symptoms of depression and changes in mood associated with smoking cessation will be assessed with the Concise Associated Symptoms Tracking (CAST) scale . Participants will work with the research clinician to set a target quit date within one week of the baseline session, and all participants will be provided written materials with guidance for smoking cessation as part of a smoking cessation counseling session. All participants will attend visits at the research clinic at 3 days and 4 weeks from target quit date to assess safety, adherence, and smoking status; participants will also receive additional smoking cessation counseling. Smoking status will be determined with exhaled breath CO and a single item questionnaire regarding the number of cigarettes smoked since target quit date and symptoms of depression and mood changes will again be measured. Medication side effects will be quantified using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale. The final study visit will occur at 8 weeks after target quit date for completion of the HSI, QIDS-SR, CAST, FIBSER, exhaled breath CO, QSU-Brief, and smoking self-report.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemfibrozil	smoking cessation counseling	Participants in this arm will receive smoking cessation counseling and will be provided gemfibrozil 600 mg twice daily by mouth for 9 weeks, starting one week prior to target quit date and ending with study completion
Waitlist	smoking cessation counseling	Participants in this arm will receive the smoking cessation counseling but will not receive medication. After completing the trial without medication, participants who continue to smoke and have a desire to quit may choose to enter the gemfibrozil arm.
Gemfibrozil	Gemfibrozil	Participants in this arm will receive smoking cessation counseling and will be provided gemfibrozil 600 mg twice daily by mouth for 9 weeks, starting one week prior to target quit date and ending with study completion

Primary Outcome Measures

Name	Time	Method
Exhaled Carbon Monoxide (CO)	8 weeks after target quit date	Exhaled carbon monoxide change from baseline to last available visit.

Secondary Outcome Measures

Name	Time	Method
Heaviness of Smoking Index	8 weeks after target quit date	The outcome measure was Heaviness of Smoking Index at exit. The Heaviness of Smoking Index is a two-item scale, with scores on each item rated on a 1-4 likert scale. The total score of the measure ranges from 2-8, with higher scores indicating worse outcome.