NCT00432575|CompletedPhase 2

Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed-Dose, 8-Week Treatment, Multi-Center Trial Evaluating the Efficacy and the Safety of 3 Oral Doses of Surinabant as an Aid to Smoking Cessation in Cigarette Smokers

Sanofi ClinicalTrials.gov

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2 other identifiers

DRI6938EUDRACT: 2006-005334-2L

Study Type

interventional

Target

810

Locations

8 countries

Sites

Timeline

RegisteredFeb 2007

StartedJan 2007

CompletionApr 2008

Brief Summary

Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine. The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

810

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach

8 countries

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

January 1, 2007

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed

Last Updated

April 15, 2009

Status Verified

April 1, 2009

Enrollment Period

1.2 years

First QC Date

February 7, 2007

Last Update Submit

April 14, 2009

Conditions

Smoking Cessation

Keywords

tobacco use cessationcigarette smokers

Outcome Measures

Primary Outcomes (1)

Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit
during the last four weeks of treatment

Secondary Outcomes (3)

Change from baseline in total body weight
8 weeks
Total score of the Questionnaire of Smoking Urges
8 weeks
Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events)
14 weeks

Study Arms (4)

1

PLACEBO COMPARATOR

Drug: placebo

2

ACTIVE COMPARATOR

surinabant 2,5 mg/day

Drug: surinabant (SR147778)

3

ACTIVE COMPARATOR

surinabant 5 mg/day

Drug: surinabant (SR147778)

4

ACTIVE COMPARATOR

surinabant 10 mg/day

Drug: surinabant (SR147778)

Interventions

surinabant (SR147778)DRUG

oral administration

234

placeboDRUG

oral administration

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients over legal age smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit.

You may not qualify if:

Patients with a limited level of motivation.
Other participant in a household enrolled in the study.
Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product more than 3 days within the 3 months preceding the screening visit.
Patients dependent to alcohol or illicit drugs.
Patients with a diagnosis of Psychotic Disorder or currently presenting with a Depressive Episode.
Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past 6 months prior to screening.
Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control.
The investigator will evaluate whether there are other reasons why a patient may not participate.

Contact the study team to confirm eligibility.