NCT00133757

Brief Summary

In this study we, the investigators at the Centre for Addiction and Mental Health, intend to explore whether bupropion is able to reduce smokers' responses to cigarette-related environmental cues, and craving. Previous studies have indicated that bupropion may be able to achieve these outcomes. Therefore, we predict that smokers treated with bupropion for several weeks will show reduced reactivity to cigarette cues and craving.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

First QC Date

August 23, 2005

Last Update Submit

February 13, 2013

Conditions

Nicotine DependenceTobacco Dependence

Keywords

TobaccoNicotineBupropionCue-reactivityCraving

Outcome Measures

Primary Outcomes (2)

  • Cue-responsiveness at pre, post, and during treatment

  • Craving at pre, post, and during treatment

Secondary Outcomes (4)

  • Attentional bias at pre and post treatment

  • Breath carbon monoxide levels at pre, post, and during treatment

  • Plasma cotinine levels at pre and post treatment

  • Puff topography measures at pre, post, and during treatment

Interventions

Bupropion SRDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females
  • At least 19 years of age
  • Smoking at least 10 cigarettes per day for at least 2 years
  • Never treated with bupropion/Zyban

You may not qualify if:

  • Co-morbid psychiatric disorder
  • History of psychotic disorder or eating disorder
  • Current alcohol or substance abuse/dependence (excluding nicotine, caffeine)
  • Brain injury
  • Seizure disorder
  • Pregnancy, lactation, or at risk of becoming pregnant
  • Current regular use of psychotropic drugs
  • Known allergy or sensitivity to bupropion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Peter Selby, MD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 24, 2005

Study Start

June 1, 2005

Study Completion

May 1, 2006

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

CA(1)