Smoking Cessation in Smokers Motivated to Quit - STRATUS-US


The goal of the trial was to evaluate the efficacy and safety of rimonabant, the first selective cannabinoid type 1 (CB1) receptor antagonist, compared with placebo for smoking cessation.


Treatment with the selective CB1 receptor antagonist rimonabant will be associated with a higher rate of smoking abstinence compared with placebo.

Study Design

Study Design:

Patients Enrolled: 787
Mean Follow Up: Mean follow-up 42 weeks
Mean Patient Age: Mean age 42 years
Female: 49

Patient Populations:

Smokers (≥10 cigarettes/day) for at least two months and motivated to stop smoking

Primary Endpoints:

Prolonged smoking abstinence

Secondary Endpoints:

Body weight changes

Drug/Procedures Used:

Patients were randomized to a fixed daily dose of rimonabant 5 mg (n=262), rimonabant 20 mg (n=261), or placebo (n=261), along with brief weekly counseling. Patients were followed for smoking abstinence and change in body weight. Self-reported smoking abstinence was confirmed by measurements of carbon monoxide concentration in expired air (≤10 ppm) and by plasma cotinine measurements.

Principal Findings:

Mean duration of regular smoking at baseline was 24 years, and mean Fagerström test for nicotine dependence total score was 5. Mean body mass index (BMI) at baseline was 27.8 kg/m2. Smoking abstinence was higher at 7-10 weeks in the high-dose rimonabant arm compared with placebo (27.6% vs. 16%), but there was no difference between the low-dose arm (15.6%) and placebo. Similar results were observed at the end of study follow-up (36.2% in the high-dose group, 20.2% in the low-dose group, 20.6% in the placebo group; p=0.002 for high-dose vs. placebo comparison).

Among patients with a prolonged abstinence from smoking, change in weight from baseline was significantly lower in the high-dose group compared with placebo (0.6 kg vs. 3.7 kg, p<0.001). In the subgroup of patients who were overweight initially, BMI was significantly lower in the high-dose group versus placebo (-0.1 vs. 1.7, p<0.001).

The most frequent adverse events in the rimonabant group were gastrointestinal. There was no difference in treatment discontinuation between groups (28.2% for high dose, 31.2% for low dose, and 27.9% for placebo).


Among patients smoking ≥10 cigarettes per day and motivated to stop smoking, use of the selective CB1 receptor antagonist rimonabant in a 20 mg dose was associated with an increase in prolonged smoking abstinence compared with placebo, but there was no difference between the 5 mg dose of rimonabant and placebo. Additionally, weight gain, which can be a negative side effect of smoking cessation, was lower in patients who received rimonabant 20 mg, with benefit seen even in obese patients.


Presented by Dr. Robert Anthenelli at the American College of Cardiology Annual Scientific Session, March 2004.

Clinical Topics: Heart Failure and Cardiomyopathies, Atherosclerotic Disease (CAD/PAD)

Keywords: Coronary Artery Disease, Follow-Up Studies, Counseling, Pyrazoles, Cotinine, Public Health, Piperidines, Body Mass Index, Cannabinoid Receptor Antagonists, Carbon Monoxide, Obesity, Receptor, Cannabinoid, CB1, Tobacco Use Disorder, Smoking Cessation

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