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CompletedNCT03346291Updated Jan 17, 2019

Examining Persistence in Smokers With Schizophrenia

An interventional study of counseling in Smoking Cessation, Schizophrenia and Schizo Affective Disorder, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-01-17.

Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Smoking Cessation
  • Schizophrenia
  • Schizo Affective Disorder
03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Persistence Targeted Smoking Cessation

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

    Behavioral: counseling

Interventions

  • Behavioralcounseling

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

05

What researchers measure

Primary outcomes

  1. Task Persistence - Mirror Tracing

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

    Time frame: Through end-of-treatment - approximately 8 weeks after baseline

  2. Task Persistence - Sustained Divided Attention Task

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

    Time frame: Through end-of-treatment - approximately 8 weeks after baseline

  3. Task Persistence - Breath-holding

    Number of seconds persisting on a breath-holding endurance task (Higher number of seconds = greater persistence)

    Time frame: Through end-of-treatment - approximately 8 weeks after baseline

  4. Task Persistence -Temperament and Character Inventory-Persistence Scale (TCI-P)

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

    Time frame: Through end-of-treatment - approximately 8 weeks after baseline

  5. Task Persistence - 2-item Task Persistence Measure

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

    Time frame: Through end-of-treatment - approximately 8 weeks after baseline

  6. Task Persistence - Distress Tolerance Scale (DTS)

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

    Time frame: Through end-of-treatment - approximately 8 weeks after baseline

  7. Task Persistence - Thoughts About Smoking Questionnaire

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

    Time frame: Through end-of-treatment - approximately 8 weeks after baseline

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

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

    Time frame: Through end-of-treatment - approximately 8 weeks after baseline

06

Study locations

1 site
  • Rutgers Robert Wood Johnson Medical School
    New Brunswick, New Jersey 08901, United States
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 26, 2018
  • Informed consent form · Nov 7, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03346291
Lead sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Marc L. Steinberg, Ph.D. (Associate Professor, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Nov 17, 2017
Start date
Jan 2017
Primary completion
Jun 13, 2018
Completion
Jun 13, 2018
Last update
Jan 17, 2019

Study contacts

Marc L Steinberg, Ph.D.
principal investigator · Rutgers, The State University of New Jersey

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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