A Phase 2 interventional study of Gemfibrozil and smoking cessation counseling in Smoking Cessation, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment
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.
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.
University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Exclusion Criteria:
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
Drug: Gemfibrozil · Behavioral: 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.
Behavioral: smoking cessation counseling
FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)
Also known as: Lopid
smoking cessation counseling
Exhaled Carbon Monoxide (CO)
Exhaled carbon monoxide change from baseline to last available visit.
Time frame: 8 weeks after target quit date
Heaviness of Smoking Index
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.
Time frame: 8 weeks after target quit date
| Milestone | Waitlist | Gemfibrozil |
|---|---|---|
| Started | 8 | 8 |
| Completed | 4 | 3 |
| Not completed | 4 | 5 |
Exhaled carbon monoxide change from baseline to last available visit.
| Parts p/million | Gemfibrozil | Waitlist |
|---|---|---|
| Exhaled Carbon Monoxide (CO) | 10.88 ± 12.63 | 21.63 ± 22.04 |
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.
| score on a scale | Waitlist | Gemfibrozil |
|---|---|---|
| Heaviness of Smoking Index | 1.25 ± 1.04 | 1.63 ± 1.30 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gemfibrozil | — | 0/8 (0%) | 1/8 (12.5%) |
| Waitlist | — | 0/8 (0%) | 1/8 (12.5%) |
| Event | Gemfibrozil | Waitlist |
|---|---|---|
| Arm bruisingSkin and subcutaneous tissue disorders | 0/8 | 1/8 |
| Abdominal painGastrointestinal disorders | 1/8 | 0/8 |
| Age, Categorical(Participants) | Waitlist | Gemfibrozil | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 8 | 16 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Waitlist | Gemfibrozil | Total |
|---|---|---|---|
| Mean | 25.25 ± 14.12 | 37.50 ± 22.02 | 31.38 ± 18.07 |
| Sex: Female, Male(Participants) | Waitlist | Gemfibrozil | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 2 | 2 | 4 |
| Region of Enrollment(Participants) | Waitlist | Gemfibrozil | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center