Open-label Pilot Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Safety as assessed by the percentage of participants that show no serious adverse events
研究概览
简要总结
The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fluent in English;
- •Diagnosed with schizophrenia spectrum disorder that is currently stable;
- •Report regular cigarette smoking, average cigarette per day ≥ 5 in the past 4 weeks, and present a breath CO≥10 ppm.
- •Meet subjective and objective (urinary drug screen) measures of non-opioid use.
- •If female, present a negative pregnancy test, not be currently breast feeding, and agree to use acceptable birth control methods and receive periodic pregnancy tests during the course of the study.
- •Able to give written informed consent
- •Obtain an Evaluation to Sign Consent (ESC) score above
- •Exclusion Criteria.
- •Have suicidal or homicidal ideation requiring immediate attention.
- •Previous use of bupropion or naltrexone in the past 30 days.
- •Currently enrolled in treatment for tobacco use.
- •Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5 )criteria for alcohol and other substance use disorders excluding nicotine and marijuana.
- •Report a history of epilepsy, seizure disorder or condition increasing risk of seizure, or head trauma with neurological sequelae.
- •Have a current eating disorder.
- •Be medically unstable or taking medications that are contraindicated with using naltrexone or bupropion.
排除标准
- 未提供
研究组 & 干预措施
Treatment
干预措施: Naltrexone (Vivitrol) (Drug)
Treatment
干预措施: Bupropion (Drug)
结局指标
主要结局
Safety as assessed by the percentage of participants that show no serious adverse events
时间窗: end of treatment (week 3)
Feasibility as assessed by the percentage of participants that enroll in the study
时间窗: end of treatment (week 3)
Percentage of participants that complete 3 weeks of treatment
时间窗: end of treatment (week 3)
次要结局
- Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS)(Baseline, end of treatment (week 3))
- Change in number of cigarettes smoked per day (CPD)(Baseline, end of treatment (week 3))
- Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU)(Baseline, end of treatment (week 3))
- Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT)(Baseline, end of treatment (week 3))
研究者
Jin Ho Yoon
Associate Professor
The University of Texas Health Science Center, Houston