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Examining Persistence in Smokers With Schizophrenia

Primary Purpose

Smoking Cessation, Schizophrenia, Schizo Affective Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

counseling

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rutgers Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Persistence Targeted Smoking Cessation

Arm Description

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

Outcomes

Primary Outcome Measures

Task Persistence - Mirror Tracing

Number of seconds persisting on a computerized mirror tracing task (Higher number of seconds = greater persistence)

Task Persistence - Sustained Divided Attention Task

Seconds persisting on Sustained Divided Attention Task (Higher number of seconds = greater persistence)

Task Persistence - Breath-holding

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)

Score on Temperament and Character Inventory-Persistence Scale (TCI-P) (Higher score = greater persistence)

Task Persistence - 2-item Task Persistence Measure

Score on 2-item Task Persistence Measure (Higher score = greater persistence)

Task Persistence - Distress Tolerance Scale (DTS)

Score on Distress Tolerance Scale (DTS) (Higher score = greater persistence)

Task Persistence - Thoughts About Smoking Questionnaire

Score on the Thoughts About Smoking Questionnaire (Higher score = less persistence)

Self-reported ratings of ease of understanding and helpfulness of counseling

percentage of participants who rate the intervention as "easy to understand" and "helpful"

Secondary Outcome Measures

Full Information

NCT ID

NCT03346291

First Posted

November 3, 2017

Last Updated

January 15, 2019

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03346291

Brief Title

Examining Persistence in Smokers With Schizophrenia

Official Title

Examining Persistence in Smokers With Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

June 13, 2018 (Actual)

Study Completion Date

June 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation, Schizophrenia, Schizo Affective Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Persistence Targeted Smoking Cessation

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

counseling

Intervention Description

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

Primary Outcome Measure Information:

Title

Task Persistence - Mirror Tracing

Description

Number of seconds persisting on a computerized mirror tracing task (Higher number of seconds = greater persistence)

Time Frame