Pilot randomized double blind, placebo controlled trial of the efficacy of simvastatin for smoking cessatio

Phase 1

Conditions: Smoking cessation
MedDRA version: 18.0Level: LLTClassification code 10008374Term: Cessation of smokingSystem Organ Class: 100000004869
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2014-004978-42-FR

Lead Sponsor: CHU DE POITIERS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: - To evaluate smoking abstinence rate. A participant is considered abstinent if he/she reports continuous abstinence from smoking confirmed by expired air carbon monoxide =8ppm and urinary cotinine concentration =10ng/mL during the last month of the 3 months treatment period.<br>- To evaluate the decrease in cigarette consumption over the 3-month period of treatment with simvastatin versus placebo<br>- To evaluate the duration of the abstinence from tobacco smoking over the 3-month period <br>- To evaluate changes in tobacco smoking behavior (craving)<br>;Main Objective: To evaluate the efficacy after a 3 months treatment by simvastatin versus placebo as an aid to quit smoking. The efficacy is estimated according the tobacco status: no reduction, reduction of 50% or more, abstinence.;Primary end point(s): Self-reported number of cigarettes smoked;Timepoint(s) of evaluation of this end point: After 3 months of simvastatin treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Self-reported continuous abstinence during the last 4 weeks of the 3 months of treatment with simvastatin versus placebo<br>- Expired air carbon monoxide = 8 ppm<br>- Urinary cotinine concentration = 10 ng/mL<br>- Nicotine craving assessed by the FTCQ-12<br>;Timepoint(s) of evaluation of this end point: After 3 months of simvastatin treatment