Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction

NCT01876810 | Completed Phase 2 Results DMC

• 1 other identifier: 082/2012
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to investigate the effect of gemfibrozil on nicotine reinforcement and cue-elicited craving. Other objectives of this study include screening for the ability of gemfibrozil to aid smoking abstinence during a brief quit attempt and examining the validity of using laboratory measures of tobacco dependence to predict smoking abstinence. It is hypothesized that gemfibrozil will result in diminished nicotine reinforcement, an attenuated response to smoking cues, and an increase in smoking abstinence compared with placebo. It is also hypothesized that the laboratory measures will prove valid in predicting abstinence.

Conditions

Nicotine Dependence

Keywords

Gemfibrozil; Nicotine Dependence; Smoking; Cigarettes

Outcome Measures

Primary Outcomes (1)

• Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks

  the number of days of no smoking was calculated for each participant. Abstinence was verified by daily Self-reports of no smoking and breath carbon monoxide \< 5 ppm

  1 week in each phase

Secondary Outcomes (1)

• The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment

  during the lab forced choice paradigm after 1 week of treatment

Other Outcomes (1)

• Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment

  during the lab Cue- reactivity paradigm after 1 week of treatment

Study Arms (2)

Gemfibrozil

EXPERIMENTAL

600 mg of gemfibrozil (one capsule) twice daily for two weeks.

Drug: Gemfibrozil

Placebo pill

PLACEBO COMPARATOR

One lactose pill twice a day for two weeks.

Drug: Placebo

Interventions

Gemfibrozil DRUG

600 mg of gemfibrozil (one capsule) twice daily for two weeks.

Also known as: Lopid

Gemfibrozil

Placebo DRUG

One lactose pill twice a day for two weeks.

Also known as: Lactose

Placebo pill

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old males and females
• smoking at least 10 cigarettes per day for at least 2 years
• intend to quit smoking within the next 3 months
• medically and psychologically healthy as determined by screening criteria

You may not qualify if:

• currently attempting to quit smoking
• treatment for tobacco addiction in the past 3 months
• use of nicotine replacement products, bupropion, or varenicline in the past 3 months as an aid to quit or reduce smoking
• use of any oral tobacco product in the past 3 months
• history of drug or alcohol dependence within last 5 years
• consumption of more than 15 alcoholic drinks per week on average during the past month
• use of any illicit drug more than once per week on average during the past month
• current use of gemfibrozil or other fibrate medication
• current use of any medication that is contraindicated for gemfibrozil or that would interfere with the protocol in the opinion of MAI/QI. This includes, but is not limited to, anticoagulants, statins, other fibrates, other lipid-lowering agents such as niacin or herbal remedies, and any oral or injected medications for diabetes.
• any pre-existing gall-bladder disease or operation in the past 12 months
• any history of or current cardiovascular, liver, hepatic or renal disease
• diabetes
• pregnant, nursing, or become pregnant during the study
• use of psychoactive drugs or medications as revealed by urine toxicology

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (2)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 1S8, Canada

Location

Centre of Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Gemfibrozil; Lactose

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; 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; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Results Point of Contact

• Title: Bernard LeFoll
• Organization: Centre for Addiction and Mental Health

bernard.lefoll@camh.ca

416-535-8501

Study Officials

• Bernard Le Foll, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 13, 2013
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 20, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (2)