Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US)

A Phase 3 study testing Rimonabant in people with Smoking Cessation, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers. The secondary study objectives were: To evaluate the effects of rimonabant on craving and weight; To evaluate the clinical and biological safety and tolerability of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking Cessation
What is being tested?: Rimonabant
How many people: 787 participants
Where: 1 siteUnited States
Study dates: Sep 2002to Aug 2003
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Smokers smoking at least 10 cigarettes/day (on average) in the 2 months preceding screening visit;
Motivated to quit smoking (Motivation Scale Score above or equal to 6 on a 10-point scale).

Who cannot join

Smoked or consumed more than 3 times within the 3 months immediately preceding the screening visit: non tobacco cigarettes or related products or any form of tobacco product other than cigarettes;
Current and regular consumption of marijuana (hashish).
Met current criteria on the MINI International Neuropsychiatric Interview (MINI) for any of the following psychiatric disorders/states: major depressive episode, dysthymia, suicidality, manic episode or hypomanic episode, panic disorder, agoraphobia, social phobia (social anxiety disorder), obsessive compulsive disorder, posttraumatic stress disorder, alcohol dependence or abuse, substance dependence or abuse (excluding nicotine or caffeine), anorexia nervosa, bulimia nervosa, or generalized anxiety disorder;
Met lifetime criteria on the MINI for manic episode or hypomanic episode, or psychotic disorders;
Carried a diagnosis of, or suspicion of any cognitive disorder (eg, delirium, dementia, amnestic disorder) or any other psychiatric or developmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) that may interfere with his/her ability to understand or complete study related procedures;
Had a history of severe depression, ie, those who have required hospitalization, or patients with 2 or more recurrent episodes of depression, or a history of multiple suicide attempts;

Show all 12Show fewer

Had used, within 3 months before the screening visit:
Nicotine replacement of any type for more than 3 days at the maximum prescribed dose, or
Behavioral and/or motivational counseling, therapy, support group, or other procedure intended to assist smoking cessation on more than 3 days, or
Bupropion (amphebutamone), or
Systemic long acting corticosteroids, or
Any therapy intended to treat or alleviate depressive symptoms (pharmacologic, somatic, or psychological) for more than 1 week.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, 19355

Other trials in United States

About this study

Official title: Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US, EFC4964) - A Randomized, Double-blind, 3-arm, Placebo-controlled, Parallel-group, Fixed-dose, 52-week, Multi-center Study.

The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary study objectives were:

To evaluate the effects of rimonabant on craving and weight;
To evaluate the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period
To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in the population of smokers);
To observe the percentage of abstinent patients during a 40-week follow-up post treatment period;
To evaluate quality of life (QOL) and pharmacoeconomics.

Conditions: Smoking Cessation
Being tested: Rimonabant
Keywords: Smoking cessation, Abstinence
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RimonabantDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Prolonged abstinence from tobacco smoking during the last 4 weeks of treatment (Day 43 to Day 70) as reported by direct inquiry of the patient by the Investigator, and confirmed by exhaled carbon monoxide (CO) levels, and plasma cotinine measurements.

Secondary outcomes (2)

Analysis of mean change from baseline to last evaluation of the total score of QSU.
Brief scale evaluating craving for tobacco cigarettes and relative change in body weight from baseline to last evaluation in patients with BMI lower than 30 kg/m2 at baseline achieving prolonged abstinence.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2002Aug 2003

First posted31 Jul 2006 (estimated)
Study startSep 2002
Primary completionAug 2003
Study completionAug 2003

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 SanofiThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 787 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00358228
Sponsor's protocol ID: EFC4964
Other IDs: SR141716
Status last verified: Dec 2010
First submitted: 28 Jul 2006
Last updated: 10 Dec 2010
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
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Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Impacto 2.0: Mobile Smoking Cessation Across Texas
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Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
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All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US, EFC4964) - A Randomized, Double-blind, 3-arm, Placebo-controlled, Parallel-group, Fixed-dose, 52-week, Multi-center Study.
ClinicalTrials.gov ID: NCT00358228
Acronym / sponsor ID: EFC4964
Conditions: Smoking Cessation
Keywords: Smoking cessation, Abstinence
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 787 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Sep 2002
Primary completion: Aug 2003 (actual)
Study completion: Aug 2003 (actual)
First posted: 31 Jul 2006 (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.

The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary study objectives were:

To evaluate the effects of rimonabant on craving and weight;
To evaluate the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period
To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in the population of smokers);
To observe the percentage of abstinent patients during a 40-week follow-up post treatment period;
To evaluate quality of life (QOL) and pharmacoeconomics.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Smokers smoking at least 10 cigarettes/day (on average) in the 2 months preceding screening visit;
Motivated to quit smoking (Motivation Scale Score above or equal to 6 on a 10-point scale).

Key exclusion criteria (12 listed)

Smoked or consumed more than 3 times within the 3 months immediately preceding the screening visit: non tobacco cigarettes or related products or any form of tobacco product other than cigarettes;
Current and regular consumption of marijuana (hashish).
Met current criteria on the MINI International Neuropsychiatric Interview (MINI) for any of the following psychiatric disorders/states: major depressive episode, dysthymia, suicidality, manic episode or hypomanic episode, panic disorder, agoraphobia, social phobia (social anxiety disorder), obsessive compulsive disorder, posttraumatic stress disorder, alcohol dependence or abuse, substance dependence or abuse (excluding nicotine or caffeine), anorexia nervosa, bulimia nervosa, or generalized anxiety disorder;
Met lifetime criteria on the MINI for manic episode or hypomanic episode, or psychotic disorders;
Carried a diagnosis of, or suspicion of any cognitive disorder (eg, delirium, dementia, amnestic disorder) or any other psychiatric or developmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) that may interfere with his/her ability to understand or complete study related procedures;

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
Rimonabant	Drug	–

Primary outcome

Prolonged abstinence from tobacco smoking during the last 4 weeks of treatment (Day 43 to Day 70) as reported by direct inquiry of the patient by the Investigator, and confirmed by exhaled carbon monoxide (CO) levels, and plasma cotinine measurements.

2 secondary outcomes

Analysis of mean change from baseline to last evaluation of the total score of QSU.
Brief scale evaluating craving for tobacco cigarettes and relative change in body weight from baseline to last evaluation in patients with BMI lower than 30 kg/m2 at baseline achieving prolonged abstinence.

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 10 Dec 2010.

Related trials for Smoking Cessation

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

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.

Lowell C. DALE, MD principal investigator

Mayo Clinic 200 First Street SW, Rochester, Minnesota 55905, US

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rimonabant in people with Smoking Cessation, run by Sanofi at 1 site in United States.

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 2 inclusion and 12 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 10 Dec 2010. 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 United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Prolonged abstinence from tobacco smoking during the last 4 weeks of treatment (Day 43 to Day 70) as reported by direct inquiry of the patient by the Investigator, and confirmed by exhaled carbon monoxide (CO) levels, and plasma cotinine measurements.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00358228.

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 10 Dec 2010.