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Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders

Primary Purpose

Nicotine Dependence, Psychotic Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Reward
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Contingency management, Smoking cessation, Psychotic disorders, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All subjects must be diagnosed with schizophrenia or any other psychotic disorder, bipolar disorder with psychotic features, or major depression with psychotic features according to the electronic medical record.
  • Current nicotine use, defined as smoking 5 or more cigarettes/day for at least 16 of the past 30 days prior to study screening.
  • Prospective subjects must indicate willingness to attend smoking cessation group therapy.

Exclusion Criteria:

  • Imminent risk for suicide or violence.
  • Severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions).
  • Clinically apparent, gross cognitive impairment.

Sites / Locations

  • VA Puget Sound Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Experimental

Active Comparator

Outcomes

Primary Outcome Measures

Number of treatment sessions attended

Secondary Outcome Measures

Reduction in cigarettes per day
7- and 30-day point prevalence abstinence
Continuous abstinence from quit date
Days to relapse from quit date
Change in BPRS scores
Change in PHQ-9 scores

Full Information

First Posted
July 27, 2007
Last Updated
June 25, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00508560
Brief Title
Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders
Official Title
Contingency Management for Smoking Cessation Among Veterans With Schizophrenia or Other Psychoses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to low recruitment.
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study examines the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses who want to quit smoking. We hypothesize that participants randomized to receive contingent rewards for group attendance will attend more treatment sessions than those in the control group.
Detailed Description
Schizophrenia and other psychotic disorders are highly prevalent in the VA population and are associated with high rates of smoking. Although smoking cessations approaches that work for non-schizophrenic patients such as behavioral counseling and medications appear to be efficacious for schizophrenic smokers, a major obstacle in providing adequate treatment is poor attendance at treatment sessions. Contingency management has been shown to shape treatment behavior in non-schizophrenic smokers and to shape other behaviors such as cocaine use and exercise in schizophrenics. The intention of this project is to examine the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses and to compare two different approaches to providing contingent incentives in this context. Subjects in the experimental condition draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. The number of draws will be based upon attendance at consecutive sessions. Subjects in the experimental condition receive a set reward that will not change regardless of attendance at consecutive sessions. We hypothesize that the participants in the experimental condition will attend more smoking cessation group therapy sessions than those in the control condition because they will have the possibility, although not the likelihood, to obtain contingent reinforcement of greater value.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Psychotic Disorders
Keywords
Contingency management, Smoking cessation, Psychotic disorders, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Participants draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. The number of draws will be based upon attendance at consecutive sessions. Tokens include messages of encouragement ("Good job!") or VA canteen vouchers of varying monetary value.
Intervention Type
Behavioral
Intervention Name(s)
Reward
Intervention Description
Participants receive set reward (VA canteen voucher) for each week of smoking cessation treatment they attend. The value of the reward will not change regardless of attendance at consecutive sessions.
Primary Outcome Measure Information:
Title
Number of treatment sessions attended
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Reduction in cigarettes per day
Time Frame
3 and 6 months
Title
7- and 30-day point prevalence abstinence
Time Frame
3 and 6 months
Title
Continuous abstinence from quit date
Time Frame
3 and 6 months
Title
Days to relapse from quit date
Time Frame
Up to 6 months
Title
Change in BPRS scores
Time Frame
3 and 6 months
Title
Change in PHQ-9 scores
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects must be diagnosed with schizophrenia or any other psychotic disorder, bipolar disorder with psychotic features, or major depression with psychotic features according to the electronic medical record. Current nicotine use, defined as smoking 5 or more cigarettes/day for at least 16 of the past 30 days prior to study screening. Prospective subjects must indicate willingness to attend smoking cessation group therapy. Exclusion Criteria: Imminent risk for suicide or violence. Severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions). Clinically apparent, gross cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J. Saxon, MD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders

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