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Trial to Evaluate the Efficacy of Simvastatin for Smoking Cessation

NCT02399709 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2020-04-13

No results posted yet for this study

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.

Conditions

  • Smoking Cessation

Interventions

DRUG

simvastatin

DRUG

Placebo

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Marie-Christine PERAULT-POCHAT, MD, PhD · Poitiers University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2015-10-08
Completion
2017-11-03

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02399709 on ClinicalTrials.gov