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Behavioral Smoking Cessation Treatment - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00110825
First received: May 13, 2005
Last updated: June 2, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention
Tobacco Use Disorder
 Behavioral: Cognitive Behavior Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Behavioral Maintenance Treatment for Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 7 day point prevalence of cigarette abstinence [ Time Frame: 8 weeks, 20 weeks, 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analog mood scales [ Time Frame: 8 weeks, 20 weeks, 52 weeks ] [ Designated as safety issue: No ]

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
    extended treatment with cognitive behavior therapy
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. P

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110825

Locations
United States, California
Stanford Stop Smoking Program
San Jose, California, United States, 95134
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Joel Killen, Ph.D. Stanford University
  More Information

Publications:

Responsible Party: Professor Joel D Killen, Stanford University
ClinicalTrials.gov Identifier: NCT00110825     History of Changes
Other Study ID Numbers: NIDA-17441-1, R01-DA17441-1, DPMCDA
Study First Received: May 13, 2005
Last Updated: June 2, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013