Conditions: Nicotine Dependence
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 1504
Healthy volunteers: no

Brief summary:
The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.

Detailed description:
This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.

Arms:
arm 1: nicotine patch alone treatment arm 2: nicotine lozenge alone treatment arm 3: nicotine patch + lozenge combination treatment arm 4: bupropion alone treatment arm 5: bupropion + nicotine lozenge combination treatment arm 6: placebo control (no active medication) treatment

Interventions: intervention 1: nicotine patch intervention 2: nicotine lozenge intervention 3: nicotine patch + nicotine lozenge intervention 4: bupropion intervention 5: bupropion + lozenge intervention 6: placebo
Intervention descriptions: intervention 1: used according to FDA package label intervention 2: used according to FDA-approved package directions intervention 3: dosage of both according to FDA-approved dosing schedule intervention 4: dosage according to FDA-approved instructions intervention 5: dosage according to FDA approved standard instructions intervention 6: dosage same as active drug conditions

Protocol document: