Examining Persistence in Smokers With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Task Persistence - Mirror Tracing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Persistence Targeted Smoking Cessation
8 weekly counseling sessions + 10 weeks of over-the-counter nicotine patch
干预措施: counseling (Behavioral)
结局指标
主要结局
Task Persistence - Mirror Tracing
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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 - Thoughts About Smoking Questionnaire
时间窗: Through end-of-treatment - approximately 8 weeks after baseline
Score on the Thoughts About Smoking Questionnaire (Higher score = less persistence)
Task Persistence - 2-item Task Persistence Measure
时间窗: 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)
时间窗: Through end-of-treatment - approximately 8 weeks after baseline
Score on Distress Tolerance Scale (DTS) (Higher score = greater persistence)
Self-reported ratings of ease of understanding and helpfulness of counseling
时间窗: Through end-of-treatment - approximately 8 weeks after baseline
percentage of participants who rate the intervention as "easy to understand" and "helpful"
次要结局
未报告次要终点
研究者
Marc L. Steinberg, Ph.D.
Associate Professor
Rutgers, The State University of New Jersey