Smoking Cessation
Conditions
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.
Interventions
DRUGGemfibrozil
FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)
BEHAVIORALsmoking cessation counseling
smoking cessation counseling
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled Carbon Monoxide (CO) | 8 weeks after target quit date | Exhaled carbon monoxide change from baseline to last available visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Waitlist Participants placed on waitlist for medication, otherwise completed study procedures | 8 |
| Gemfibrozil Received gemfibrozil tablets | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Gemfibrozil | Waitlist | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Continuous | 37.50 Years STANDARD_DEVIATION 22.02 | 25.25 Years STANDARD_DEVIATION 14.12 | 31.38 Years STANDARD_DEVIATION 18.07 |
| Region of Enrollment United States | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Exhaled Carbon Monoxide (CO)
Exhaled carbon monoxide change from baseline to last available visit.
Time frame: 8 weeks after target quit date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gemfibrozil | Exhaled Carbon Monoxide (CO) | 10.88 Parts p/million | Standard Deviation 12.63 |
| Waitlist | Exhaled Carbon Monoxide (CO) | 21.63 Parts p/million | Standard Deviation 22.04 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gemfibrozil | Heaviness of Smoking Index | 1.25 score on a scale | Standard Deviation 1.04 |
| Waitlist | Heaviness of Smoking Index | 1.63 score on a scale | Standard Deviation 1.3 |