Clinical trial NCT03346291: Examining Persistence in Smokers With Schizophrenia
Official title: Examining Persistence in Smokers With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Schizophrenia
Schizo Affective Disorder
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-11-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Task Persistence - Mirror Tracing
timeFrame: Through end-of-treatment - approximately 8 weeks after baseline
measure: Task Persistence - Sustained Divided Attention Task
timeFrame: Through end-of-treatment - approximately 8 weeks after baseline
measure: Task Persistence - Breath-holding
timeFrame: Through end-of-treatment - approximately 8 weeks after baseline
measure: Task Persistence -Temperament and Character Inventory-Persistence Scale (TCI-P)
timeFrame: Through end-of-treatment - approximately 8 weeks after baseline
measure: Task Persistence - 2-item Task Persistence Measure
timeFrame: Through end-of-treatment - approximately 8 weeks after baseline
measure: Task Persistence - Distress Tolerance Scale (DTS)
timeFrame: Through end-of-treatment - approximately 8 weeks after baseline
measure: Task Persistence - Thoughts About Smoking Questionnaire
timeFrame: Through end-of-treatment - approximately 8 weeks after baseline
measure: Self-reported ratings of ease of understanding and helpfulness of counseling
timeFrame: Through end-of-treatment - approximately 8 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Marc L Steinberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: