NCT00136760

Brief Summary

There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2003

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

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

December 17, 2012

Completed
Last Updated

October 7, 2015

Status Verified

April 1, 2013

Enrollment Period

5.5 years

First QC Date

August 25, 2005

Results QC Date

November 16, 2012

Last Update Submit

October 5, 2015

Conditions

Schizophrenia and Disorders With Psychotic FeaturesTobacco Use Disorder

Keywords

tobacco

Outcome Measures

Primary Outcomes (1)

  • Urinary Cotinine

    Urinary Cotinine levels at Week 4 (average of last 3 study visits)

    3 weeks

Secondary Outcomes (1)

  • Cigarettes Smoked Per Day

    3 weeks

Study Arms (4)

1

EXPERIMENTAL

Contingent reinforcement plus bupropion

Drug: Bupropion

2

EXPERIMENTAL

Contingent reinforcement plus placebo

Drug: Contingent reinforcement plus placebo

3

EXPERIMENTAL

Non-contingent reinforcement plus bupropion

Drug: non-contingent reinforcement plus bupropion

4

PLACEBO COMPARATOR

Non-contingent reinforcement plus placebo

Drug: Non-contingent reinforcement plus placebo

Interventions

BupropionDRUG

Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)

Also known as: zyban, wellbutrin
1
Contingent reinforcement plus placeboDRUG

contingent reinforcement plus placebo (3 weeks)

2
non-contingent reinforcement plus bupropionDRUG

non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)

Also known as: zyban, wellbutrin
3
Non-contingent reinforcement plus placeboDRUG

Non-contingent reinforcement plus placebo

4

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications

You may not qualify if:

  • Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (2)

  • Tidey JW, Rohsenow DJ, Kaplan GB, Swift RM, Reid N. Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia. Psychopharmacology (Berl). 2011 Sep;217(2):279-87. doi: 10.1007/s00213-011-2282-8. Epub 2011 Apr 8.

    PMID: 21475970RESULT

  • Tidey JW. Using incentives to reduce substance use and other health risk behaviors among people with serious mental illness. Prev Med. 2012 Nov;55 Suppl(Suppl):S54-60. doi: 10.1016/j.ypmed.2011.11.010. Epub 2011 Dec 9.

    PMID: 22197799RESULT

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic DisordersTobacco Use Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Mental DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Jennifer Tidey, Ph.D.
Organization
Brown University
Jennifer_Tidey@brown.edu
401-863-6418

Study Officials

  • Jennifer W. Tidey

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Research), Dept Psychiatry and Human Behavior

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

September 1, 2003

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 7, 2015

Results First Posted

December 17, 2012

Record last verified: 2013-04

Locations

US(1)