Maintaining Abstinence in Chronic Cigarette Smokers - 1

NCT ID: NCT00087880

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2009-09-30

Brief Summary

The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bupropion and NRT

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Bupropion and NRT

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Bupropion and NRT

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Bupropion and NRT

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Bupropion and NRT

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Zyban

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

University California, San Francisco

Principal Investigators

Sharon M Hall, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University California, San Francisco

San Francisco, California, United States

Countries

United States

References

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type: DERIVED

PMID: 37230961 (View on PubMed)

Other Identifiers

R01-15732-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-15732-1

Identifier Type: -

Identifier Source: org_study_id