Examining Persistence in Smokers With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Examining Persistence in Smokers With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346291
• Other study ID #: 20150001885
• Secondary ID: R21DA041163-01
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 13, 2018

Study information

• Verified date: January 2019
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia
• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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