Maintaining Abstinence in Chronic Cigarette Smokers - 1

Tobacco Use Disorder Clinical Trial

Official title:

Maintaining Abstinence in Chronic Cigarette Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087880
• Other study ID #: NIDA-15732-1
• Secondary ID: R01-15732-1
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2004
• Last updated: January 11, 2017
• Start date: December 2002
• Est. completion date: September 2009

Study information

• Verified date: March 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: September 2009
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Behavior		2	No