Behavioral Maintenance Treatment for Smoking Cessation
2 other identifiers
interventional
304
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2004
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedMarch 3, 2016
March 1, 2016
2.1 years
October 7, 2010
March 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
expired-air carbon monoxide confirmed 7-day point prevalence smoking abstinence
expired-air carbon monoxide \< 10 ppm and self report of no smoking for 7 consecutive days prior to assessment
52 weeks
Secondary Outcomes (1)
depression symptoms
52 weeks
Study Arms (2)
Open Label CBT and Pharmacotherapy
NO INTERVENTIONAll study participants received 8 weeks of cognitive and behavioral cessation and relapse prevention skills training (CBT) and nicotine patch therapy combined with 9 weeks of bupropion SR therapy. Following open-label, this group received general supportive therapy delivered via four telephone calls made to participants over a 12-week period.
Behavioral: cognitive behavior therapy
EXPERIMENTALAll study participants received 8 weeks of cognitive and behavioral cessation and relapse prevention skills training (CBT) and nicotine patch therapy combined with 9 weeks of bupropion SR therapy. Following open-label treatment, half the participants received an additional 12 weeks of CBT that combined clinic-based skills training sessions, voicemail monitoring and telephone counseling
Interventions
At each clinic session, staff met with participants individually for 30 minutes to develop cognitive and behavioral skills to resist urges to smoke. Staff used self-efficacy questionnaires to assess participants' confidence in their abilities to resist urges to smoke in specific situations and behavioral worksheets to help participants articulate treatment plans to be used in managing their behavior in these situations without smoking. Those participants randomized to extended CBT continued to work with treatment staff individually on the development and use of cognitive and behavioral cessation and relapse prevention skills. Treatment sessions, lasting approximately 30 minutes, were conducted at the San Jose clinic site at weeks 8, 12, 16 and 20.
Eligibility Criteria
You may qualify if:
- Healthy adult cigarette smokers smoking at least 10 cigarettes per day
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
Stanford Stop Smoking Program
San Jose, California, 95131, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (2)
Bailey SR, Hammer SA, Bryson SW, Schatzberg AF, Killen JD. Using treatment process data to predict maintained smoking abstinence. Am J Health Behav. 2010 Nov-Dec;34(6):801-10. doi: 10.5993/ajhb.34.6.14.
PMID: 20604703BACKGROUNDKillen JD, Fortmann SP, Schatzberg AF, Arredondo C, Murphy G, Hayward C, Celio M, Cromp D, Fong D, Pandurangi M. Extended cognitive behavior therapy for cigarette smoking cessation. Addiction. 2008 Aug;103(8):1381-90. doi: 10.1111/j.1360-0443.2008.02273.x.
PMID: 18855829RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel D Killen
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
October 7, 2010
First Posted
June 11, 2012
Study Start
February 1, 2004
Primary Completion
March 1, 2006
Study Completion
June 1, 2009
Last Updated
March 3, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share