ADDICSTATINE: Trial to Evaluate the Efficacy of Simvastatin for Smoking Cessation

Sponsor

Poitiers University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02399709

Collaborator

(none)

124

Enrollment

Location

Arms

31.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Drug: simvastatin Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Pilot Randomized Double Blind, Placebo Controlled Trial of the Efficacy of Simvastatin for Smoking Cessation

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Oct 8, 2015

Actual Study Completion Date :

Nov 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: simvastatin oral administration, capsule of 20mg.	Drug: simvastatin
Placebo Comparator: microcrystalline cellulose oral administration, capsule of 20mg	Drug: Placebo

Arm

Intervention/Treatment

Experimental: simvastatin

oral administration, capsule of 20mg.

Drug: simvastatin

Placebo Comparator: microcrystalline cellulose

oral administration, capsule of 20mg

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Self-reported number of cigarettes smoked [After 3 months of simvastatin treatment]

Secondary Outcome Measures

Self-reported continuous abstinence during the last 4 weeks of the 3 months of treatment with simvastatin versus placebo [After 3 months of simvastatin treatment]
Expired air carbon monoxide ≤ 8 ppm [After 3 months of simvastatin treatment]
Urinary cotinine concentration ≤ 10 ng/mL [After 3 months of simvastatin treatment]
Nicotine craving assessed by the FTCQ-12 [After 3 months of simvastatin treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poitiers University Hospital	Poitiers		France	86000

Sponsors and Collaborators

Poitiers University Hospital

Investigators

Principal Investigator: Marie-Christine PERAULT-POCHAT, MD, PhD, Poitiers University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT02399709

Other Study ID Numbers:

ADDICSTATINE

First Posted:

Mar 26, 2015

Last Update Posted:

Apr 13, 2020

Last Verified:

Apr 1, 2020

Additional relevant MeSH terms:

Simvastatin

Study Results

No Results Posted as of Apr 13, 2020