Behavioral Maintenance Treatment for Smoking Cessation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking
- Sponsor
- Stanford University
- Enrollment
- 304
- Locations
- 2
- Primary Endpoint
- expired-air carbon monoxide confirmed 7-day point prevalence smoking abstinence
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. The investigators will also conduct secondary analyses of mediators and moderators of treatment response.
Detailed 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.
Investigators
Joel D Killen
Principle Investigator
Stanford University
Eligibility Criteria
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)
Outcomes
Primary Outcomes
expired-air carbon monoxide confirmed 7-day point prevalence smoking abstinence
Time Frame: 52 weeks
expired-air carbon monoxide \< 10 ppm and self report of no smoking for 7 consecutive days prior to assessment
Secondary Outcomes
- depression symptoms(52 weeks)