Clinical trial NCT02399709: Trial to Evaluate the Efficacy of Simvastatin for Smoking Cessation
Official title: Pilot Randomized Double Blind, Placebo Controlled Trial of the Efficacy of Simvastatin for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tobacco smoking is the number one preventable cause of disease worldwide. Unfortunately, there are few smoking cessation agents and their effectiveness has been shown to be relatively limited and is associated with potential unwanted effects. Therefore, the discovery of new medications that can facilitate abstinence and reduce relapse to cigarette use represents a pressing necessity. In the attempt to find molecules that could reduce drug-seeking behavior, we discovered that simvastatin reduces cocaine and nicotine, but not food, seeking behavior in rats. This discovery of a new therapeutic application for an already marketed class of compounds may greatly facilitate the translation from preclinical to clinical setting. In this project, we aim at investigating whether simvastatin is an effective smoking cessation agent in humans.

The study design is a multicenter, randomized, double blind 2 parallel groups, clinical trial with an intention-to-treat analysis. Smokers will randomly be assigned to receive simvastatin or placebo for 3 months. 200 smokers (100 receiving simvastatin and 100 receiving placebo) will be recruited through already established networks of general practitioners. The primary outcome of the efficacy of simvastatin will be the rate of smoking abstinence during the last month of the 3-month treatment period, defined as reported continuous abstinence from smoking and confirmed by expired air carbon monoxide and urinary cotinine concentration. The last assessment will be done 6 months after the predefined quit date.

The results of this proof-of-concept study may open new perspectives in the treatment of tobacco use and dependance.


Eligibility criteria: Inclusion Criteria:

* Age \>=18 and \<=70 years,
* Smoking more than 10 cigarettes per day for at least 1 year,
* Motivated to quit smoking,
* Without legal tutors or subordination,
* Affiliated to a health insurance system as required by the French law on biomedical research,
* Written informed consent for participation in the study.

Exclusion Criteria:

* Age \< 18 or \> 70 years,
* Presenting a contraindication to simvastatin use,
* With depression and/or psychosis and/or cognitive disorder and/or mental retardation or chronic use of medications for these disorders,
* Substance use disorder other than smoking,
* More than 3 months of abstinence from cigarette smoking in the previous year,
* Use of nicotine replacement therapy, bupropion, varenicline on last 3 months,
* Use of clonidine or nortriptyline on last 3 months,
* Undergoing on last 3 months' cognitive-behavioral therapy for smoking cessation,
* Premenopausal women without contraception.

Primary outcomes:
measure: Self-reported number of cigarettes smoked
timeFrame: After 3 months of simvastatin treatment
Secondary outcomes:
measure: Self-reported continuous abstinence during the last 4 weeks of the 3 months of treatment with simvastatin versus placebo
timeFrame: After 3 months of simvastatin treatment
measure: Expired air carbon monoxide ≤ 8 ppm
timeFrame: After 3 months of simvastatin treatment
measure: Urinary cotinine concentration ≤ 10 ng/mL
timeFrame: After 3 months of simvastatin treatment
measure: Nicotine craving assessed by the FTCQ-12
timeFrame: After 3 months of simvastatin treatment
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital
Study officials:
affiliation: Poitiers University Hospital
name: Marie-Christine PERAULT-POCHAT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: