Schizo Affective Disorder, Schizophrenia, Smoking Cessation
Conditions
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.
Interventions
BEHAVIORALcounseling
individual, weekly, smoking cessation counseling + over-the-counter nicotine patch
Sponsors
National Institute on Drug Abuse (NIDA)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Task Persistence - Mirror Tracing | Through end-of-treatment - approximately 8 weeks after baseline | Number of seconds persisting on a computerized mirror tracing task (Higher number of seconds = greater persistence) |
| Task Persistence - Sustained Divided Attention Task | Through end-of-treatment - approximately 8 weeks after baseline | Seconds persisting on Sustained Divided Attention Task (Higher number of seconds = greater persistence) |
| Task Persistence - Breath-holding | Through end-of-treatment - approximately 8 weeks after baseline | Number of seconds persisting on a breath-holding endurance task (Higher number of seconds = greater persistence) |
| Task Persistence -Temperament and Character Inventory-Persistence Scale (TCI-P) | Through end-of-treatment - approximately 8 weeks after baseline | Score on Temperament and Character Inventory-Persistence Scale (TCI-P) (Higher score = greater persistence) |
| Task Persistence - 2-item Task Persistence Measure | Through end-of-treatment - approximately 8 weeks after baseline | Score on 2-item Task Persistence Measure (Higher score = greater persistence) |
| Task Persistence - Distress Tolerance Scale (DTS) | Through end-of-treatment - approximately 8 weeks after baseline | Score on Distress Tolerance Scale (DTS) (Higher score = greater persistence) |
| Task Persistence - Thoughts About Smoking Questionnaire | Through end-of-treatment - approximately 8 weeks after baseline | Score on the Thoughts About Smoking Questionnaire (Higher score = less persistence) |
| Self-reported ratings of ease of understanding and helpfulness of counseling | Through end-of-treatment - approximately 8 weeks after baseline | percentage of participants who rate the intervention as easy to understand and helpful |
Countries
United States
Outcome results
None listed