NCT00129272

Brief Summary

Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2004

Longer than P75 for phase_2

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

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

April 18, 2017

Completed
Last Updated

May 22, 2017

Status Verified

April 1, 2017

Enrollment Period

6.7 years

First QC Date

August 4, 2005

Results QC Date

January 16, 2017

Last Update Submit

April 17, 2017

Conditions

Tobacco Use CessationTobacco Use Disorder

Keywords

adolescents, cigarettes, smoking, tobacco

Outcome Measures

Primary Outcomes (1)

  • Smoking Behavior

    Number of cigarettes smoked daily in the previous week

    Nine weeks

Secondary Outcomes (1)

  • Withdrawal Symptoms

    Nine weeks

Study Arms (2)

Bupropion (Wellbutrin-SR)

ACTIVE COMPARATOR

Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.

Drug: Bupropion-SR

Matching Placebo

PLACEBO COMPARATOR

Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.

Other: Placebo

Interventions

Bupropion-SRDRUG

150mg tablets taken orally twice daily for 9 weeks.

Also known as: Wellbutrin-SR
Bupropion (Wellbutrin-SR)
PlaceboOTHER

Matching placebo (to Buproion-SR) twice daily for 9 weeks.

Also known as: Placebo match for Bupropion (Wellbutrin) SR
Matching Placebo

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Has smoked at least 10 cigarettes each day for 3 or more months
  • Weighs at least 90 lbs
  • Motivated to quit smoking and has had at least one previous failed attempt
  • Speaks, reads, and writes English
  • Either diagnosed as depressed OR no history of a psychiatric disorder

You may not qualify if:

  • History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, autism, or non-nicotine substance use disorder in the 6 months prior to study entry
  • Currently suicidal or with a history of a suicide attempt in the 6 months prior to study entry
  • Psychotic symptoms
  • Use of psychotropic medication(s)
  • Serious medical condition
  • Prior use of bupropion for smoking cessation
  • Currently using other smoking cessation treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390 9101, United States

Location

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

Tobacco Use CessationTobacco Use DisorderSmoking

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Uma Rao, MD
Organization
The University of Tennessee
urao@utk.edu
615-794-3351

Study Officials

  • Uma Rao, MD

    University of Texas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 11, 2005

Study Start

May 1, 2004

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

May 22, 2017

Results First Posted

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)