Maintaining Abstinence in Chronic Cigarette Smokers - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00087880
First received: July 15, 2004
Last updated: March 28, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.

Condition Intervention Phase
Tobacco Use Disorder
Drug: Bupropion and NRT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintaining Abstinence in Chronic Cigarette Smokers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Smoking Behavior [ Time Frame: 2 ] [ Designated as safety issue: No ]

Enrollment: 407
Study Start Date: December 2002
Study Completion Date: September 2009
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brief Treatment
Participants will start with a 21 mg nicotine patch, tapering to 14 mg patch and finally tapering to 7 mg patch. The nicotine patch will be administered on Week 3 of the program. Participants will meet with medical staff during Weeks 1, 2, 5, and 11. Five group counseling sessions must be attended by the participants. Assessments will be conducted on Weeks 12, 24, 36, 52, 64, and 104.
Drug: Bupropion and NRT
All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104.
Other Name: Zyban
Active Comparator: Extended Bupropion/Low Contact
Participants will receive the Brief Treatment followed by ongoing Bupropion treatment through Week 52. Participants will meet with medical staff once a month.
Drug: Bupropion and NRT
All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104.
Other Name: Zyban
Placebo Comparator: Extended Placebo/Low Contact
Participants will receive the Brief Treatment followed by placebo medication (sugar-pill) through Week 52 and meet with medical staff once a month.
Drug: Bupropion and NRT
All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104.
Other Name: Zyban
Active Comparator: Extended Bupropion/High Contact
Participants will receive Brief Treatment followed by ongoing bupropion treatment through Week 52. Participants will attending counseling session 20-40 minutes in duration and will be scheduled at weeks 12, 14, 16, 18, 20, 24, 28, 32, 36, 44, and 52. The contents of these sessions will introduce additional information focusing on motivation, social support, mood management, weight gain, and dependence/withdrawal. Subjects will be contact by phone between counseling sessions (at Weeks 13, 15, 18, 22, 26, 30, 34, 36, 40, 48) for a brief check-in.
Drug: Bupropion and NRT
All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104.
Other Name: Zyban
Placebo Comparator: Extended Placebo/High Contact
Participants receive the Brief Treatment followed by a placebo medication through Week 52 and meet with medical staff once per month. Participants will attending counseling session 20-40 minutes in duration and will be scheduled at weeks 12, 14, 16, 18, 20, 24, 28, 32, 36, 44, and 52. The contents of these sessions will introduce additional information focusing on motivation, social support, mood management, weight gain, and dependence/withdrawal. Subjects will be contact by phone between counseling sessions (at Weeks 13, 15, 18, 22, 26, 30, 34, 36, 40, 48) for a brief check-in.
Drug: Bupropion and NRT
All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104.
Other Name: Zyban

Detailed Description:
The work adapts interventions that have been successful in the general populations, and tailors them to chronic smokers, who may have numerous previous smoking treatment failures. If successful it will: (1) make available a treatment intervention that produces hight long term abstinence rates; (2) provide information on variables that predicts success and failure in this population of smokers; (3) examine the cost-effectiveness of more intensive, longer term treatments.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Subjects (N=400) will be men and women (50%) over the age of 18 who smoke at least 10 cigarettes per day and answers yes to the question "Do you smoke within 30 minutes of arising?"

Inclusion Criteria:

-Subjects are age 18 and over, currently smoking 10 or more cigarettes per day, and report a smoking history of at least 5 years in response to the question "How long have you been a regular smoker?"

Exclusion Criteria:

  • History of seizure or head injury resulting in unconsciousness
  • Any condition that might predispose to seizures (brain tumor or stroke)
  • A current or history of anorexia nervosa or bulimia
  • Any disease acutely life-threatening or so severe that the patient is judged unable to comply with the protocol
  • Use of a protease inhibitor of MAO inhibitor within the last two week
  • Current use of psychiatric drugs that would interfere with interpretation of study results, including antidepressants
  • Treatment for alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol
  • Patients who know they are leaving the Bay Area within the study period and non-English speakers will be excluded
  • Suicidal or homicidal ideation
  • Current major depression
  • History of bipolar disorder
  • Recent (within twelve months) myocardial infarction
  • Any other medical condition that would contraindicate use of NRT or bupropion
  • Physical limitation so severe that participation in a program of moderate exercise is not possible
  • Pregnancy or lactation
  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: NCT00087880

Locations
United States, California
University California, San Francisco
San Francisco, California, United States, 94143-0984
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Sharon M Hall, Ph.D. University of California, San Francisco
  More Information

Responsible Party: Sharon M. Hall, Ph.D, University California, San Francisco
ClinicalTrials.gov Identifier: NCT00087880     History of Changes
Other Study ID Numbers: NIDA-15732-1  R01-15732-1 
Study First Received: July 15, 2004
Last Updated: March 28, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
smoking cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016