Conditions: Obesity Overweight
Keywords: Obesity Behavior Modification
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 793
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.

Detailed description:
The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg). Combining pharmacotherapy with a comprehensive program of diet, exercise and group lifestyle modification counseling may provide the best weight loss regimen. This study evaluated weight loss in subjects participating in such a comprehensive program who received a combination of naltrexone SR and bupropion SR, or placebo.

Arms:
arm 1: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group lifestyle modification counseling arm 2: Placebo with intensive group lifestyle modification counseling

Interventions: intervention 1: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day intervention 2: Placebo intervention 3: Intensive group lifestyle modification counseling
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: