NCT00006170

Brief Summary

The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2000

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2000

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

November 14, 2013

Completed
Last Updated

July 21, 2016

Status Verified

June 1, 2016

Enrollment Period

9.3 years

First QC Date

August 9, 2000

Results QC Date

June 18, 2013

Last Update Submit

June 22, 2016

Conditions

Tobacco Use Disorder

Keywords

smoking cessationWomenbupropionweight concernsweight

Outcome Measures

Primary Outcomes (3)

  • Smoking Abstinence

    Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \>15 micrograms/L were used to confirm non-smoking.

    3 months

  • Smoking Abstinence

    Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \>15 micrograms/L were used to confirm non-smoking.

    6 months

  • Smoking Abstinence

    Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \>15 micrograms/L were used to confirm non-smoking.

    12 months

Study Arms (4)

Bupropion and Weight Concerns intervention

EXPERIMENTAL

Bupropion SR and a weight concerns psychosocial intervention

Drug: BupropionBehavioral: weight concerns intervention

Placebo and Weight Concerns

ACTIVE COMPARATOR

A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion

Drug: PlaceboBehavioral: weight concerns intervention

Bupropion and standard smoking cessation

ACTIVE COMPARATOR

Bupropion SR and a time and attention controlled smoking cessation intervention

Drug: BupropionBehavioral: smoking cessation intervention

Placebo and standard smoking cessation

PLACEBO COMPARATOR

A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention

Drug: PlaceboBehavioral: smoking cessation intervention

Interventions

BupropionDRUG

smoking cessation medication aid

Also known as: zyban
Bupropion and Weight Concerns interventionBupropion and standard smoking cessation
PlaceboDRUG

A matched placebo pill

Placebo and Weight ConcernsPlacebo and standard smoking cessation
weight concerns interventionBEHAVIORAL

cognitive behavioral treatment to address weight concners

Bupropion and Weight Concerns interventionPlacebo and Weight Concerns
smoking cessation interventionBEHAVIORAL

Cognitive behavioral intervention for smoking cessation

Bupropion and standard smoking cessationPlacebo and standard smoking cessation

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoke at least 10 cigarettes per day
  • Report concern about cessation-related weight gain
  • Motivated to quit smoking

You may not qualify if:

  • Currently pregnant, lactating, or no medically approved method of contraception
  • Major medical problem
  • History of seizure disorder or head injury
  • Current or historical psychosis or bipolar disorder
  • History of alcohol or substance abuse within previous year
  • Current or historical eating disorder
  • Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month
  • Multiple Drug Allergies
  • Current major depressive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, 15213 2593, United States

Location

Related Publications (2)

  • Levine MD, Perkins KA, Kalarchian MA, Cheng Y, Houck PR, Slane JD, Marcus MD. Bupropion and cognitive behavioral therapy for weight-concerned women smokers. Arch Intern Med. 2010 Mar 22;170(6):543-50. doi: 10.1001/archinternmed.2010.33.

    PMID: 20308641RESULT

  • 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

Tobacco Use DisorderSmoking CessationBody Weight

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Dr. Michele Levine
Organization
University of Pittsburgh
levinem@upmc.edu
412-647-0703

Study Officials

  • Marsha Marcus, Ph.D.

    Western Psychiatric Institute & Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

August 9, 2000

First Posted

August 10, 2000

Study Start

September 1, 2000

Primary Completion

December 1, 2009

Study Completion

September 1, 2010

Last Updated

July 21, 2016

Results First Posted

November 14, 2013

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)