Examining Persistence in Smokers With Schizophrenia

Rutgers The State University of New Jersey

Status

Completed

Conditions

Schizophrenia

Schizo Affective Disorder

Smoking Cessation

Treatments

Behavioral: counseling

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03346291

R21DA041163-01 (U.S. NIH Grant/Contract)

20150001885

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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