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A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling


Phase 4
18 Years
N/A
Not Enrolling
Both
Tobacco Dependence, Smoking

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Trial Information

A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling


Inclusion Criteria:



- Smoke 10 or more cigarettes per day

- Expired carbon monoxide (CO) level greater than 9 parts per million (ppm)

- Motivated to quit smoking (score of 3 on 4-point self-report scale)

- Willing to fulfill study requirements

Exclusion Criteria:

- Carbon monoxide breath test score below 9 ppm

- Serious psychopathology (bipolar disorder, psychosis)

- Center for Epidemiologic Studies Depression Scale CES-D)score over 16

- Contraindications for use of bupropion

- History of seizure disorder

- History of eating disorder

- Current heavy drinking

- Risk of pregnancy

- Current breastfeeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

7-day point prevalence abstinence from smoking at 6 months

Outcome Description:

No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Timothy B Baker, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin School of Medicine and Public Health

Authority:

United States: Institutional Review Board

Study ID:

1998-369

NCT ID:

NCT01621009

Start Date:

January 2001

Completion Date:

October 2003

Related Keywords:

  • Tobacco Dependence
  • Smoking
  • smoking cessation medications
  • smoking cessation counseling
  • Smoking
  • Tobacco Use Disorder

Name

Location
UW Center for Tobacco Research and Intervention Madison, Wisconsin  53711