Nicotine DependenceNCT00508560
Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders
A study testing Contingency Management and Reward in people with Nicotine Dependence and Psychotic Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence, Psychotic Disorders
- What is being tested?
- Contingency Management and Reward
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98109
About this study
Official title: Contingency Management for Smoking Cessation Among Veterans With Schizophrenia or Other Psychoses
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.
Read the 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.
- Conditions
- Nicotine Dependence, Psychotic Disorders
- Being tested
- Contingency Management, Reward
- Keywords
- Contingency management, Smoking cessation, Psychotic disorders, Veterans
- Medical subject headings
- Tobacco Use Disorder, Psychotic Disorders, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
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.
RewardBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Experimental Receives: Behavioral: Contingency Management |
| Arm 2 | Active comparator | Active Comparator Receives: Behavioral: Reward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment sessions attended
Measured: 11 weeks
Secondary outcomes (6)
Reduction in cigarettes per day
Measured: 3 and 6 months
7- and 30-day point prevalence abstinence
Measured: 3 and 6 months
Continuous abstinence from quit date
Measured: 3 and 6 months
Days to relapse from quit date
Measured: Up to 6 months
Change in BPRS scores
Measured: 3 and 6 months
Change in PHQ-9 scores
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Stopped due to low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Andrew J. Saxon, MD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508560
- Sponsor's protocol ID
- SUD-Q
- Status last verified
- Jun 2015
- First submitted
- 27 Jul 2007
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management for Smoking Cessation Among Veterans With Schizophrenia or Other Psychoses
- ClinicalTrials.gov ID
- NCT00508560
- Acronym / sponsor ID
- SUD-Q
- Conditions
- Nicotine Dependence, Psychotic Disorders
- Keywords
- Contingency management, Smoking cessation, Psychotic disorders, Veterans
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to low recruitment.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Contingency ManagementExperimental |
| Arm 2 | Active comparator | Behavioral: RewardActive Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementParticipants 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. | Behavioural | Arm 1 |
| RewardParticipants 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. | Behavioural | Arm 2 |
Primary outcome
Number of treatment sessions attended
Time frame: 11 weeks
6 secondary outcomes
Reduction in cigarettes per day
Time frame: 3 and 6 months
7- and 30-day point prevalence abstinence
Time frame: 3 and 6 months
Continuous abstinence from quit date
Time frame: 3 and 6 months
Days to relapse from quit date
Time frame: Up to 6 months
Change in BPRS scores
Time frame: 3 and 6 months
Change in PHQ-9 scores
Time frame: 3 and 6 months
Results and safety
The study was stopped early (reason given: Stopped due to low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J. Saxon, MD principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management and Reward in people with Nicotine Dependence and Psychotic Disorders, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Stopped due to low recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment sessions attended (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.