Extended Treatment for Smoking Cessation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01330043
First received: October 7, 2010
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.


Condition Intervention
Smoking Cessation
Behavioral: cognitive behavior therapy (CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Treatment for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • smoking abstinence [ Time Frame: 52 and 104 week follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • smoking relapse [ Time Frame: 52 and 104 week follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cognitive behavioral therapy
Participants will be randomized to receive extended cognitive behavioral therapy for an additional six months beyond the initial 26-week intervention. Those who do not receive extended cognitive behavioral therapy will receive a monthly phone call asking about their smoking status and will not receive any treatment.
Behavioral: cognitive behavior therapy (CBT)
During open label treatment, all receive CBT and zyban and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. Medication will not be available after week 26. All will receive CBT through week 26.

Detailed Description:

During open label treatment, all receive CBT and zyban and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and nicotine replacement therapy (NRT) through week 26. Medication will not be available after week 26. All will receive CBT through week 26.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack)

Exclusion Criteria:

  1. Currently pregnant
  2. Currently breastfeeding
  3. Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus
  4. History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
  5. Family history of seizures
  6. Currently using intravenous drugs
  7. Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
  8. Currently using any over-the-counter stimulants and anorectics (diet pills)
  9. Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
  10. Currently on NRT or bupropion (Zyban)
  11. Current or past diagnosis of anorexia nervosa or bulimia nervosa
  12. Previous allergic response to bupropion or NRT
  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 ClinicalTrials.gov identifier: NCT01330043

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sean P. David, M.D., D.Phil. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01330043     History of Changes
Obsolete Identifiers: NCT01067612
Other Study ID Numbers: SU-09272010-6949, R01DA017441
Study First Received: October 7, 2010
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
smoking cessation intervention

ClinicalTrials.gov processed this record on October 19, 2014