Maintaining Abstinence in Chronic Cigarette Smokers - 1
2 other identifiers
interventional
407
1 country
1
Brief Summary
The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 15, 2004
CompletedFirst Posted
Study publicly available on registry
July 19, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJanuary 12, 2017
March 1, 2016
2.1 years
July 15, 2004
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking Behavior
2
Study Arms (5)
Brief Treatment
ACTIVE COMPARATORParticipants 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.
Extended Bupropion/Low Contact
ACTIVE COMPARATORParticipants will receive the Brief Treatment followed by ongoing Bupropion treatment through Week 52. Participants will meet with medical staff once a month.
Extended Placebo/Low Contact
PLACEBO COMPARATORParticipants will receive the Brief Treatment followed by placebo medication (sugar-pill) through Week 52 and meet with medical staff once a month.
Extended Bupropion/High Contact
ACTIVE COMPARATORParticipants 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.
Extended Placebo/High Contact
PLACEBO COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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?"
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University California, San Francisco
San Francisco, California, 94143-0984, United States
Related Publications (1)
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.
PMID: 37230961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon M Hall, Ph.D.
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 15, 2004
First Posted
July 19, 2004
Study Start
December 1, 2002
Primary Completion
January 1, 2005
Study Completion
September 1, 2009
Last Updated
January 12, 2017
Record last verified: 2016-03