Examining Persistence in Smokers With Schizophrenia

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 13, 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Persistence Targeted Smoking Cessation
    • 8 weekly counseling sessions + 10 weeks of over-the-counter nicotine patch

Clinical Trial Outcome Measures

Primary Measures

  • Task Persistence – Mirror Tracing
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Through end-of-treatment – approximately 8 weeks after baseline
    • percentage of participants who rate the intervention as “easy to understand” and “helpful”

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marc L. Steinberg, Ph.D., Associate Professor – Rutgers, The State University of New Jersey
  • Overall Official(s)
    • Marc L Steinberg, Ph.D., Principal Investigator, Rutgers, The State University of New Jersey

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.