Smoking CessationPhase 2ADDICSTATINENCT02399709
Trial to Evaluate the Efficacy of Simvastatin for Smoking Cessation
A Phase 2 study testing simvastatin in people with Smoking Cessation, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2015to 3 Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- Use of clonidine or nortriptyline on last 3 months,
- Undergoing on last 3 months' cognitive-behavioral therapy for smoking cessation,
- Premenopausal women without contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Double Blind, Placebo Controlled Trial of the Efficacy of Simvastatin for Smoking Cessation
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
- Being tested
- simvastatin, Placebo
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| simvastatin | Experimental | oral administration, capsule of 20mg. Receives: Drug: simvastatin |
| microcrystalline cellulose | Placebo comparator | oral administration, capsule of 20mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported number of cigarettes smoked
Measured: After 3 months of simvastatin treatment
Secondary outcomes (4)
Self-reported continuous abstinence during the last 4 weeks of the 3 months of treatment with simvastatin versus placebo
Measured: After 3 months of simvastatin treatment
Expired air carbon monoxide ≤ 8 ppm
Measured: After 3 months of simvastatin treatment
Urinary cotinine concentration ≤ 10 ng/mL
Measured: After 3 months of simvastatin treatment
Nicotine craving assessed by the FTCQ-12
Measured: After 3 months of simvastatin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study start1 Apr 2015
- Primary completion8 Oct 2015
- Study completion3 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Christine PERAULT-POCHAT, MD, PhD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399709
- Sponsor's protocol ID
- ADDICSTATINE
- Acronym
- ADDICSTATINE
- Status last verified
- Apr 2020
- First submitted
- 20 Mar 2015
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Double Blind, Placebo Controlled Trial of the Efficacy of Simvastatin for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02399709
- Acronym / sponsor ID
- ADDICSTATINE / ADDICSTATINE
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 8 Oct 2015 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simvastatin | Experimental | Drug: simvastatinoral administration, capsule of 20mg. |
| microcrystalline cellulose | Placebo comparator | Drug: Placebooral administration, capsule of 20mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simvastatin | Drug | simvastatin |
| Placebo | Drug | microcrystalline cellulose |
Primary outcome
Self-reported number of cigarettes smoked
Time frame: After 3 months of simvastatin treatment
4 secondary outcomes
Self-reported continuous abstinence during the last 4 weeks of the 3 months of treatment with simvastatin versus placebo
Time frame: After 3 months of simvastatin treatment
Expired air carbon monoxide ≤ 8 ppm
Time frame: After 3 months of simvastatin treatment
Urinary cotinine concentration ≤ 10 ng/mL
Time frame: After 3 months of simvastatin treatment
Nicotine craving assessed by the FTCQ-12
Time frame: After 3 months of simvastatin treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Christine PERAULT-POCHAT, MD, PhD principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing simvastatin in people with Smoking Cessation, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported number of cigarettes smoked (time frame: After 3 months of simvastatin treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.