Behavioral Treatment Development for Co-occurring Opioid Dependence and Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Urine-confirmed Self-reported Weeks of Opioid Use
研究概览
简要总结
Anxiety is highly prevalent among individuals with opioid dependence and confers greater risk for continued opioid use and poor treatment outcomes. However, there are currently no efficacious treatments available for co-occurring opioid dependence and anxiety. The ultimate aims of this trial are the development and testing of a novel integrated cognitive behavioral treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This clinical trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We hypothesize that I-CBT will be a feasible and acceptable treatment that will result in significant reductions in anxiety and opioid use.
详细描述
This Stage 1 behavioral treatment development trial involves two stages: manual development and pilot testing in an open trial, and a small randomized controlled trial. In both phases, opioid use and anxiety symptoms will be measured as the primary clinical outcome, along with measures of feasibility and patient satisfaction. These results will be used to further refine the treatment manual and to evaluate whether this treatment may enhance outcomes for adults with co-occurring opioid dependence and anxiety disorders.
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
- Single (Outcomes Assessor)
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
- •age 18 or older
- •meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition diagnostic criteria for opioid use disorder
- •currently prescribed pharmacotherapy for opioid dependence
- •have used opioids illicitly within the previous 90 days
- •clinically-significant anxiety
- •meet current diagnostic criteria for a Diagnostic and Statistical Manual of Mental Disorders 5th edition anxiety disorder
- •able to read and provide informed consent
- •intend to remain in the geographical area for the duration of the study period
排除标准
- •meet criteria for a current substance use or psychiatric disorder requiring a level of care higher than outpatient
- •currently receiving cognitive behavioral therapy
- •recent initiation of a psychiatric medication, defined as less than 4 weeks on a stable dose; not including PRN medications for sleep
- •are receiving and taking an as-needed (PRN) prescription for benzodiazepines
- •presence of a psychiatric or medical condition that would interfere with participation or that requires additional care (e.g. psychosis, acute suicidality)
- •were admitted to McLean Hospital for their current treatment episode on an involuntary status
结局指标
主要结局
Urine-confirmed Self-reported Weeks of Opioid Use
时间窗: Week 12
Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen
Anxiety Symptom Severity
时间窗: Week 12
Hamilton Anxiety Rating Scale (HADS) score. Measure assesses the severity of anxiety symptoms. Total scale scores are reported. Higher scores reflect worse outcome. The range of possible scores is 0-56.
次要结局
- Non-opioid Substance Use(Week 12)
- Functional Impairment(Week 12)
- Quality of Life - General Health Score(Week 12)
研究者
McHugh, R. Kathryn
Associate Psychologist, Division of Alcohol and Drug Abuse
Mclean Hospital