Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to better characterize differences in mood, attention, brain activation patterns underlying the beneficial effects of pharmacological treatments previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2) nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week intensive post-treatment follow-up. In addition, 20 percent of the subjects will be randomized to a delayed-quit control group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern Illinois University Carbondale
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Bupropion; Nicotine

Criteria

Inclusion Criteria:Inclusion Criteria:

• Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) diagnosis of nicotine dependence with psychological dependence

• Smokes at least 10 cigarettes per day for the three months prior to enrollment

• Currently seeking treatment for nicotine dependence

• Medically healthy on the basis of physical examination and medical history, vital signs,

• Females must use an effective method of contraception for the duration of the study

Exclusion Criteria:

• DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine

• Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment

• History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders

• Currently seeking treatment for nicotine disorders

• History of seizures or head trauma with loss of consciousness, brain contusion, or fracture

• History of significant recent violent behavior

• Blood pressure greater than 150/90

• History of eating disorders

• History of allergic reaction to any of the study medications

• Pregnant