Gemfibrozil for Nicotine Smoking Cessation (GEMNIC)
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ClinicalTrials.gov Identifier: NCT02638597 |
Recruitment Status :
Completed
First Posted : December 23, 2015
Results First Posted : February 1, 2019
Last Update Posted : February 1, 2019
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Condition or disease | Intervention/treatment | Phase |
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Smoking Cessation | Drug: Gemfibrozil Behavioral: smoking cessation counseling | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Gemfibrozil for Nicotine Smoking Cessation |
Study Start Date : | February 2015 |
Actual Primary Completion Date : | December 23, 2016 |
Actual Study Completion Date : | December 23, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: 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
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Drug: Gemfibrozil
FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)
Other Name: Lopid Behavioral: smoking cessation counseling smoking cessation counseling |
Waitlist
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.
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Behavioral: smoking cessation counseling
smoking cessation counseling |
- Exhaled Carbon Monoxide (CO) [ Time Frame: 8 weeks after target quit date ]Exhaled carbon monoxide change from baseline to last available visit.
- Heaviness of Smoking Index [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638597
United States, Texas | |
Parkland Memorial Hospital | |
Dallas, Texas, United States, 75235 |
Principal Investigator: | Madhukar Trivedi, MD | University of Texas Southwestern Medical Center |
Responsible Party: | Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT02638597 |
Other Study ID Numbers: |
STU 072014-088 |
First Posted: | December 23, 2015 Key Record Dates |
Results First Posted: | February 1, 2019 |
Last Update Posted: | February 1, 2019 |
Last Verified: | January 2019 |
Gemfibrozil Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
Lipid Regulating Agents Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |