Behavioral Smoking Cessation Treatment - 1

National Institutes of Health (NIH)

Status

Completed

Conditions

Tobacco Use Disorder

Treatments

Behavioral: Cognitive Behavior Therapy

Study type

Interventional

Funder types

NIH

Identifiers

NCT00110825

DPMCDA

R01-DA17441-1

NIDA-17441-1

Details and patient eligibility

About

Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. We will also conduct secondary analyses of mediators and moderators of treatment response.

Full description

400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All smokers will receive the same "Acute Phase Treatment" that combines nicotine patch, bupropion and intensive self-regulatory skills training. Nicotine patches will be provided for 8 weeks and bupropion and skills training will be provided for of 9 weeks. Participants will then enter a "Maintenance Treatment Phase" during which half (n=200) will receive three individualized relapse prevention training sessions spread over a 12 week period. They will also receive 12 weeks of self-administered RPT administered via written treatment modules. Finally, telephone counseling will be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=200) will be assigned to a control condition that consists of three counselor-led sessions of "supportive therapy" spread over a 12 week period. P

Enrollment

304 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adult cigarette smokers smoking at least 10 cigarettes per day

Exclusion criteria

Currently pregnant
Currently breastfeeding
Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure
History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
Family history of seizures
Currently using intravenous drugs
Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
Currently using any over-the-counter stimulants and anorectics (diet pills)
Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
Currently on NRT or bupropion (Zyban)
Current or past diagnosis of anorexia nervosa or bulimia nervosa
Previous allergic response to bupropion or NRT
Previous failed quit attempt using NRT and bupropion in combination