Skip to main content
OpenTrials
Completed

NCT Number: NCT03346291

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Health Behavior Mental Disorders Psychotic Disorders Schizo Affective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Behavioral

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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"

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.