GEMNIC: Gemfibrozil for Nicotine Smoking Cessation

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02638597
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 22.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Drug: Gemfibrozil; Behavioral: smoking cessation counseling	Phase 2

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.

Study Design

• Study Type: Interventional
• 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: Feb 1, 2015
• Actual Primary Completion Date: Dec 23, 2016
• Actual Study Completion Date: Dec 23, 2016

Arms and Interventions

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	Drug: Gemfibrozil; FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use); Other Names: Lopid ; Behavioral: smoking cessation counseling; smoking cessation counseling
Other: 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.	Behavioral: smoking cessation counseling; smoking cessation counseling

Outcome Measures

Primary Outcome Measures

1. Exhaled Carbon Monoxide (CO) [8 weeks after target quit date]

   Exhaled carbon monoxide change from baseline to last available visit.

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkland Memorial Hospital	Dallas	Texas	United States	75235

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Madhukar Trivedi, MD, University of Texas Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. Erratum in: Biol Psychiatry. 2003 Sep 1;54(5):585.
• Trivedi MH, Wisniewski SR, Morris DW, Fava M, Kurian BT, Gollan JK, Nierenberg AA, Warden D, Gaynes BN, Luther JF, Rush AJ. Concise Associated Symptoms Tracking scale: a brief self-report and clinician rating of symptoms associated with suicidality. J Clin Psychiatry. 2011 Jun;72(6):765-74. doi: 10.4088/JCP.11m06840.
• Wisniewski SR, Rush AJ, Balasubramani GK, Trivedi MH, Nierenberg AA; STARD Investigators. Self-rated global measure of the frequency, intensity, and burden of side effects. J Psychiatr Pract. 2006 Mar;12(2):71-9.

• Responsible Party: Madhukar H. Trivedi, MD, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02638597
• Other Study ID Numbers: STU 072014-088
• First Posted: Dec 23, 2015
• Last Update Posted: Feb 1, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Gemfibrozil

Study Results

Participant Flow

Arm/Group Title	Waitlist	Gemfibrozil
Arm/Group Description	Participants placed on waitlist for medication, otherwise completed study procedures	Received gemfibrozil tablets
Period Title: Overall Study
STARTED	8	8
COMPLETED	4	3
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	Waitlist	Gemfibrozil	Total
Arm/Group Description	Participants placed on waitlist for medication, otherwise completed study procedures	Received gemfibrozil tablets	Total of all reporting groups
Overall Participants	8	8	16
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 100%	8 100%	16 100%
>=65 years	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	25.25 (14.12)	37.50 (22.02)	31.38 (18.07)
Sex: Female, Male (Count of Participants)
Female	6 75%	6 75%	12 75%
Male	2 25%	2 25%	4 25%
Region of Enrollment (Count of Participants)
United States	8 100%	8 100%	16 100%

Outcome Measures

1. Primary Outcome

Title	Exhaled Carbon Monoxide (CO)
Description	Exhaled carbon monoxide change from baseline to last available visit.
Time Frame	8 weeks after target quit date

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gemfibrozil	Waitlist
Arm/Group Description	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 Gemfibrozil: FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use) smoking cessation counseling: 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. smoking cessation counseling: smoking cessation counseling
Measure Participants	8	8
Mean (Standard Deviation) [Parts p/million]	10.88 (12.63)	21.63 (22.04)

2. Secondary Outcome

Title	Heaviness of Smoking Index
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Waitlist	Gemfibrozil
Arm/Group Description	Participants placed on waitlist for medication, otherwise completed study procedures	Received gemfibrozil tablets
Measure Participants	8	8
Mean (Standard Deviation) [score on a scale]	1.25 (1.04)	1.63 (1.30)

Adverse Events

Arm/Group Title	Gemfibrozil		Waitlist
Arm/Group Description	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 Gemfibrozil: FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use) smoking cessation counseling: 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. smoking cessation counseling: smoking cessation counseling
All Cause Mortality
	Gemfibrozil		Waitlist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Gemfibrozil		Waitlist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Gemfibrozil		Waitlist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)		1/8 (12.5%)
Gastrointestinal disorders
Abdominal pain	1/8 (12.5%)	1	0/8 (0%)	0
Skin and subcutaneous tissue disorders
Arm bruising	0/8 (0%)	0	1/8 (12.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.