Maintaining Abstinence in Chronic Cigar… | Clinical Trial

Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University California, San Francisco

San Francisco, California, 94143-0984, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupropion and NRT

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.

Other names: Zyban

Primary outcomes

Smoking Behavior

Time frame: 2

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Maintaining Abstinence in Chronic Cigarette Smokers

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2009
First posted: Jul 19, 2004
Registry last updated: Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed