Examining Persistence in Smokers With Schizophrenia

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 Overview

• Status: Completed
• Conditions: Smoking Cessation; Schizophrenia; Schizo Affective Disorder
• Intervention / Treatment: Behavioral: counseling

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Marc L Steinberg, Ph.D., Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 13, 2018
• Study Completion (Actual): June 13, 2018

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mood Disorders
• Other Study ID Numbers: 20150001885; R21DA041163-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No