Examining Persistence in Smokers With Schizophrenia

NCT03346291 | Completed DMC

• 2 other identifiers: 20150001885R21DA041163-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Schizophrenia; Schizo Affective Disorder

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Persistence Targeted Smoking Cessation

EXPERIMENTAL

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

Behavioral: counseling

Interventions

counseling BEHAVIORAL

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

Persistence Targeted Smoking Cessation

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Schizophrenia; Psychotic Disorders

Interventions

Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marc L Steinberg, Ph.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2017
• Primary Completion: June 13, 2018
• Study Completion: June 13, 2018
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)