Examining Persistence in Smokers With Schizophrenia

Study Overview
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Brief Summary
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All participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.

Detailed Description
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This study is a non-randomized trial of a new psychosocial treatment for smoking cessation (for smokers with schizophrenia) that is based on cognitive behavioral therapy for smoking cessation - a commonly used approach. Participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.

Official Title
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Examining Persistence in Smokers With Schizophrenia

Conditions
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Smoking Cessation, Schizophrenia, Schizo Affective Disorder

Intervention / Treatment
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* Behavioral: counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be between 18 - 64 years old Must indicate commitment to quitting smoking in the next 30 days Must smoke at least 5 cigarettes per day for past 6-months Expired breath carbon monoxide (CO) > 5 to ensure daily cigarette use Must score < 8 (or <7 for women) on the Alcohol Use Disorders Identification Test Must score less than 3 on the 6-month Drug Abuse Screening Test-10 Must provide a negative urine drug screen for cannabis, cocaine, opiates, or methamphetamine (Note: Participants with a positive screen for opiates may participate with proof of prescription for opiates.) Must have a diagnosis of Schizophrenia or Schizoaffective Disorder on Structured Clinical Interview Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen including a stable antipsychotic dose for 8 weeks Exclusion Criteria: Must not be currently receiving tobacco dependence treatment counseling Must not currently be taking varenicline (Chantix) Must not be taking bupropion (Zyban/Wellbutrin) to quit smoking Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days. Must not report unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days Must not be pregnant, breastfeeding, or planning on becoming pregnant in the next 4-months. Women who can become pregnant may be included if using effective birth control Must not have pending legal matters with potential to result in jail time Must not be planning on moving outside local area in next 3-months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Persistence Targeted Smoking Cessation<br>8 weekly counseling sessions + 10 weeks of over-the-counter nicotine patch | Behavioral: counseling<br>* individual, weekly, smoking cessation counseling + over-the-counter nicotine patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Task Persistence - Mirror Tracing | Number of seconds persisting on a computerized mirror tracing task (Higher number of seconds = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline | 
| Task Persistence - Sustained Divided Attention Task | Seconds persisting on Sustained Divided Attention Task (Higher number of seconds = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline | 
| Task Persistence - Breath-holding | Number of seconds persisting on a breath-holding endurance task (Higher number of seconds = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline | 
| Task Persistence -Temperament and Character Inventory-Persistence Scale (TCI-P) | Score on Temperament and Character Inventory-Persistence Scale (TCI-P) (Higher score = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline | 
| Task Persistence - 2-item Task Persistence Measure | Score on 2-item Task Persistence Measure (Higher score = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline | 
| Task Persistence - Distress Tolerance Scale (DTS) | Score on Distress Tolerance Scale (DTS) (Higher score = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline | 
| Task Persistence - Thoughts About Smoking Questionnaire | Score on the Thoughts About Smoking Questionnaire (Higher score = less persistence) | Through end-of-treatment - approximately 8 weeks after baseline | 
| Self-reported ratings of ease of understanding and helpfulness of counseling | percentage of participants who rate the intervention as easy to understand and helpful | Through end-of-treatment - approximately 8 weeks after baseline |