Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)
研究概览
简要总结
This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced medication management intervention will accompany all treatment conditions. Follow-up assessments will be completed at 9 and 12 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Meets criteria for alcohol dependence and post-traumatic stress disorder.
- •Heavy drinking in the past 30 days (an average of more than 12 alcohol drinks per week with at least 1 day of 4 or more drinks).
- •Successfully complete medical detoxification.
- •Exhibit clinically significant trauma-related symptoms.
- •Live in a commutable distance to the University of Pennsylvania and agree to follow-up visits.
- •Aged between 18 and 65 years old.
- •Able to provide an informed consent.
- •Speak and read English.
排除标准
- •Current diagnosis of any substance dependence other than alcohol, nicotine, or cannabis.
- •Evidence of opiate use in the past 30 days.
- •Significant risk of violence or history of serious violent behavior during the past year.
- •Continued contact with an intimate partner if assault by the partner is the index trauma.
- •Changes in dosage or medication for any SSRI treatment in the three months prior to entering the study.
- •Unstable or serious medical illness.
- •Current severe psychiatric symptom.
- •Mental retardation or another pervasive developmental disorder.
- •Use of an investigational medication in the past 30 days.
- •Pregnant, nursing or not using reliable contraception.
研究组 & 干预措施
Naltrexone with CBT for PTSD
Naltrexone with CBT for PTSD
干预措施: Naltrexone (Drug)
Naltrexone alone
Naltrexone alone
干预措施: Naltrexone (Drug)
Naltrexone with CBT for PTSD
Naltrexone with CBT for PTSD
干预措施: Cognitive-Behavioral Therapy (Behavioral)
Placebo with CBT for PTSD
Placebo with CBT for PTSD
干预措施: Cognitive-Behavioral Therapy (Behavioral)
Placebo alone
Placebo alone
干预措施: Placebo (Drug)
结局指标
主要结局
Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)
时间窗: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Drinking Timeline Follow-back Interview (TFBI)
时间窗: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.
次要结局
- Penn Alcohol Cravings Scale(Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up))