Examining Persistence in Smokers With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-06-13

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.

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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.

Conditions

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Smoking Cessation Schizophrenia Schizo Affective Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Persistence Targeted Smoking Cessation

8 weekly counseling sessions + 10 weeks of over-the-counter nicotine patch

Group Type EXPERIMENTAL

counseling

Intervention Type BEHAVIORAL

individual, weekly, smoking cessation counseling + over-the-counter nicotine patch

Interventions

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counseling

individual, weekly, smoking cessation counseling + over-the-counter nicotine patch

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No