Status:
COMPLETED
Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Nicotine Dependence
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
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 gemfibrozi...
Detailed Description
Animal studies have shown that drugs acting as agonists at alpha-type peroxisome proliferator-activated receptors (PPARα) suppress nicotine self-administration, attenuate relapse to nicotine-seeking b...
Eligibility Criteria
Inclusion
- 19-65 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01876810
Start Date
February 1 2014
End Date
February 1 2016
Last Update
April 20 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 1S8
2
Centre of Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1