Behavioral Maintenance Treatment for Smoking Cessation

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Stanford University Identifier:
First received: October 7, 2010
Last updated: June 6, 2012
Last verified: June 2012
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
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

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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)
Intervention Details:
    Behavioral: cognitive behavior therapy
    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.
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01615770

United States, California
Stanford Stop Smoking Program
San Jose, California, United States
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Joel D Killen Stanford University
  More Information

Responsible Party: Stanford University 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 processed this record on February 10, 2016