A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Timeline Follow Back (TLFB)
研究概览
简要总结
The proposed study is a 4-site, 12-week, novel, feasibility, investigation of patients who have co-occurring diagnoses of schizophrenia and current substance use disorder (alcohol, cocaine, heroin, or cannabis). Thirty-nine participants will be randomly assigned to switch to brexpiprazole (the brexpiprazole group) or remain on the same antipsychotic treatment (the control group). The study will be conducted at 4 sites in the US. The investigators expect to enroll 80 subjects across 3 sites. UMass Medical School, Worcester MA is the lead site. Sub-sites include Massachusetts General Hospital (MGH) and the University of North Carolina at Chapel Hill (UNC).
详细描述
STUDY OBJECTIVES
The primary objectives of the study include:
- examine the effect of brexpiprazole treatment on the number of days of substance use in the past week as measured by the Timeline Follow-Back (TLFB) assessment;
- examine the effect of brexpiprazole treatment on substance craving using 100-mm visual analogue scale (VAS).
The secondary objectives are to examine the effect of brexpiprazole treatment on:
- the dollar amount spent on substances in the past week;
- the psychiatric symptoms as measured by various clinical rating scales
- quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old
- •Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder and substance use disorder (alcohol, cocaine, heroin, or cannabis) based on the Mini International Neuropsychiatric Interview for the DSM-5 (MINI 7.0)
- •Uses substance on at least 4 of the past 30 days prior to randomization with at least one use in the week prior to randomization for one of substances (cocaine, heroin, cannabis or alcohol) assessed by the TLFB interview
- •Stable dose of antipsychotic agent for at least one month
- •Well established compliance with outpatient medications
- •Female subjects of child-bearing potential are required to practice appropriate birth control methods during the study.
排除标准
- •Psychiatrically unstable
- •Currently meets DSM-5 criteria for any substance use disorder other than caffeine, nicotine, alcohol, cocaine, heroin and cannabis
- •Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
- •History of a seizure disorder
- •Pregnancy or breastfeeding
- •Currently on aripiprazole or cariprazine
- •Currently on medications to treat substance use (disulfiram, naltrexone, acamprosate, methadone, buprenorphine, varenicline or buproprion)
研究组 & 干预措施
Experimental
Brexpiprazole 4mg daily for 12 weeks
干预措施: Brexpiprazole (Drug)
Treatment as Usual
Stay on current antipsychotic medication for 12 weeks
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Timeline Follow Back (TLFB)
时间窗: 12 weeks
The Timeline Follow Back (TLFB) scale is used to measure weekly substance use for alcohol, marijuana, cocaine, and/or heroin by assessing the number of days a person used substances in the past week, on a scale from 0 to 7 \[0 = no substances that week; 7 = substance use every day\]. The outcome measure was the number of days per week that participants used a substance. If participants use more than one substance, only the primary substance (one used mostly frequently) was analyzed. While the TLFB was assessed weekly, the outcome measure reported is the change in substance use between Week 0 (Baseline) and Week 12 (End of Study). A decrease in number of days/week that substances were used indicates an improved (better) outcome. While the TLFB was assessed weekly, the outcome measure reported is the change in substance use between Week 0 (Baseline) and Week 12 (End of Study). A decrease in number of days/week that substances were used indicates an improved (better) outcome.
Visual Analog Scale (VAS)
时间窗: 12 weeks
The Visual Analog Scale (VAS) measures substance craving. Subjects will make a mark on an unlabeled 100-millimeter line indicating their desire to use a particular substance over the past 7-days. A score of 0 indicates no desire to use and 100 indicating the strongest desire to use possible. The assessment was done weekly. Subjects reported craving for any substances they used that week with a separate mark for each substance (e.g., a mark for alcohol craving and another mark for marijuana). For outcome measures, only the primary substance (the substance used most frequently, as determined by the Timeline Follow Back assessment) was included. While cravings were assessed weekly, only the change in craving from Week 0 (Baseline) to Week 12 (End of Study) is reported; a decreased score (reduction in cravings) represents an improved outcome.
次要结局
- Amount of Money Spent on Substances(12 weeks)
- Positive and Negative Symptom Scale (PANSS)(12 Weeks)
- Clinical Global Impression - Severity(12 Weeks)
- Heinrichs Carpenter Quality of Life Scale (QOL)(12 Weeks)
研究者
Xiaoduo Fan, MD, MPH
Associate Professor of Psychiatry
University of Massachusetts, Worcester