Gemfibrozil for Nicotine Smoking Cessation

NCT02638597 | Completed Phase 2 Results

• 1 other identifier: STU 072014-088
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Exhaled Carbon Monoxide (CO)

  Exhaled carbon monoxide change from baseline to last available visit.

  8 weeks after target quit date

Secondary Outcomes (1)

• Heaviness of Smoking Index

  8 weeks after target quit date

Study Arms (2)

Gemfibrozil

EXPERIMENTAL

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

Waitlist

OTHER

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

Interventions

Gemfibrozil DRUG

FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)

Also known as: Lopid

Gemfibrozil

smoking cessation counseling BEHAVIORAL

smoking cessation counseling

Gemfibrozil; Waitlist

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

Related Publications (3)

• 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. doi: 10.1016/s0006-3223(02)01866-8.

  PMID: 12946886 BACKGROUND

• 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.

  PMID: 21733477 BACKGROUND

• 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. doi: 10.1097/00131746-200603000-00002.

  PMID: 16728903 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Interventions

Gemfibrozil

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Texas Southwestern Medical Center

madhukar.trivedi@UTSouthwestern.edu

2146480188

Study Officials

• Madhukar Trivedi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Madhukar H. Trivedi, MD

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 23, 2015
• Study Start: February 1, 2015
• Primary Completion: December 23, 2016
• Study Completion: December 23, 2016
• Last Updated: February 1, 2019
• Results First Posted: February 1, 2019

Record last verified: 2019-01

Locations

US (1)