Gemfibrozil for Nicotine Smoking Cessation

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.

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