Examining Persistence in Smokers With Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia; Smoking Cessation; Schizo Affective Disorder
• Interventions: Behavioral: counseling

• Registration Number: NCT03346291
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Primary Completion: 2018-06-13
• Study Completion: 2018-06-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Persistence Targeted Smoking Cessation	counseling	8 weekly counseling sessions + 10 weeks of over-the-counter nicotine patch

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rutgers Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States