Behavioral Maintenance Treatment for Smoking Cessation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Smoking |
Behavioral: cognitive behavior therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Behavioral Maintenance Treatment for Smoking Cessation |
- expired-air carbon monoxide confirmed 7-day point prevalence smoking abstinence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]expired-air carbon monoxide < 10 ppm and self report of no smoking for 7 consecutive days prior to assessment
- depression symptoms [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]symptoms of depression measured with the CES-D
| Enrollment: | 304 |
| Study Start Date: | February 2004 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
-
Behavioral: cognitive behavior therapy
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| Stanford Stop Smoking Program | |
| San Jose, California, United States | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Joel D Killen | Stanford University |
More Information
Publications:
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01615770 History of Changes |
| Other Study ID Numbers: | SU-09282010-6951, RO1-DA017441 |
| Study First Received: | October 7, 2010 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 21, 2013