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

Pilot randomized double blind, placebo controlled trial of the efficacy of simvastatin for smoking cessation - ADDICTSTATINE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004978-42-FR

Enrollment

Unknown

Registered

2015-06-19

Start date

2015-02-25

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking cessation MedDRA version: 18.0 Level: LLT Classification code 10008374 Term: Cessation of smoking System Organ Class: 100000004869

Interventions

Trade Name: simvastatin ZOCOR®40 mg Product Name: ZOCOR Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >=18 and =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Age 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

Design outcomes

Primary

Measure	Time frame
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. - To evaluate the decrease in cigarette consumption over the 3-month period of treatment with simvastatin versus placebo - To evaluate the duration of the abstinence from tobacco smoking over the 3-month period - To evaluate changes in tobacco smoking behavior (craving) ;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	—

Measure

Time frame

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. - To evaluate the decrease in cigarette consumption over the 3-month period of treatment with simvastatin versus placebo - To evaluate the duration of the abstinence from tobacco smoking over the 3-month period - To evaluate changes in tobacco smoking behavior (craving) ;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

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

Countries

France

Contacts

Public ContactABRIAT FANNY

CHU DE POITIERS

fanny.abriat@chu-poitiers.fr0549443796

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026