Phase 2
Completed N=16
Gemfibrozil for Nicotine Smoking Cessation
Source: ClinicalTrials.gov NCT02638597 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Exhaled Carbon Monoxide (CO) — 10.88; 21.63 Parts p/million
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exhaled Carbon Monoxide (CO) |
10.88; 21.63 | — |
| SECONDARY Heaviness of Smoking Index |
1.25; 1.63 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02638597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.