NCT00218231

Brief Summary

Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Jan 2004

Typical duration for phase_2 schizophrenia

Geographic Reach
1 country

2 active sites

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

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2008

Enrollment Period

2.6 years

First QC Date

September 16, 2005

Last Update Submit

January 11, 2017

Conditions

SchizophreniaTobacco Use Disorder

Keywords

schizophreniatobacco dependencenicotine

Outcome Measures

Primary Outcomes (1)

  • Smoking behavior

    after 5 hrs abstinence

Secondary Outcomes (3)

  • Adverse events

    ongoing

  • urge to smoke

    after 5 hrs abstinence

  • nicotine withdrawal symptoms

    after 5 hrs withdrawal

Study Arms (2)

1

EXPERIMENTAL

300 mg/day bupropion-sr

Drug: 300 mg/day bupropion-sr

2

PLACEBO COMPARATOR

0 mg bupropion-sr

Drug: 0 mg/day bupropion-sr

Interventions

300 mg/day bupropion-srDRUG

300 mg/day for 1 week

Also known as: zyban, wellbutrin
1
0 mg/day bupropion-srDRUG

0 mg/day bupropion-sr

Also known as: placebo
2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with schizophrenia or schizo-affective disorder
  • Smokes between 20 and 50 cigarettes per day
  • Moderate to high nicotine dependence score
  • Interest in quitting smoking

You may not qualify if:

  • Currently trying to quit smoking
  • Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics
  • Alcohol or drug use disorders
  • Requires certain medications
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Providence VA Medical Center, RI

Providence, Rhode Island, 02908, United States

Location

Brown University

Providence, Rhode Island, 02912, 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

SchizophreniaTobacco Use Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Jennifer W. Tidey

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

January 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 12, 2017

Record last verified: 2008-08

Locations

US(2)