NCT00508560

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

5.4 years

First QC Date

July 27, 2007

Last Update Submit

June 25, 2015

Conditions

Keywords

Contingency managementSmoking cessationPsychotic disordersVeterans

Outcome Measures

Primary Outcomes (1)

  • Number of treatment sessions attended

    11 weeks

Secondary Outcomes (6)

  • Reduction in cigarettes per day

    3 and 6 months

  • 7- and 30-day point prevalence abstinence

    3 and 6 months

  • Continuous abstinence from quit date

    3 and 6 months

  • Days to relapse from quit date

    Up to 6 months

  • Change in BPRS scores

    3 and 6 months

  • +1 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

Experimental

Behavioral: Contingency Management

Arm 2

ACTIVE COMPARATOR

Active Comparator

Behavioral: Reward

Interventions

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.

Arm 1
RewardBEHAVIORAL

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.

Arm 2

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderPsychotic DisordersSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersHealth BehaviorBehavior

Study Officials

  • Andrew J. Saxon, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 30, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations