Adolescent Community Reinforcement Approach (A-CRA) Implementation in Combination With Buprenorphine/Naloxone for Young Adults Ages 18 to 25 With Severe Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percent of days of opioid use within the past 90 days as indicated by self-report on the Global Appraisal of Individual Needs
研究概览
简要总结
The study assesses whether adding a behavioral intervention, known as the Adolescent Community Reinforcement Approach (A-CRA), to the treatment of individuals already receiving buprenorphine/naloxone can improve treatment success and retention rates in young adults with severe opioid use disorder.
详细描述
Buprenorphine is one of the medication assisted treatments approved by the FDA for opioid use disorders. Treatment with buprenorphine/naloxone may reduce the risk of opioid overdose and lower the occurrence of further conditions associated with injection drug use such as psychiatric disorders, hepatitis C infection, HIV, and high-risk sexual and criminal behaviors. The study assesses whether adding a behavioral intervention, known as the Adolescent Community Reinforcement Approach (A-CRA), to the treatment of individuals already receiving buprenorphine/naloxone can improve treatment success and retention rates in young adults with severe opioid use disorder.
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 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have met DSM-5 criteria for severe opioid use disorder
- •no sensitivity to buprenorphine or naloxone
- •no further medical/addictive conditions that require immediate medical attention
- •ability to read and provide informed consent
- •intent to remain in the area for the duration of the study
- •able to receive outpatient care
- •agreed to use an acceptable birth control method throughout the duration of this study (female participants)
排除标准
- •endorsement of imminent and serious suicidality
- •medical conditions that take precedence over the presence of treatment for an addictive disorder
- •history of an adverse reaction to buprenorphine/naloxone
- •current substance use or psychiatric condition requiring a level of care higher than outpatient
- •pregnant, nursing or planning pregnancy during the extent of the treatment trial(female participants)
结局指标
主要结局
Percent of days of opioid use within the past 90 days as indicated by self-report on the Global Appraisal of Individual Needs
时间窗: Pre-treatment (baseline) and post-study intervention (12 weeks visit after completion of A-CRA ), and end of follow-up (24-week visit) .
The Global Appraisal of Individual Needs is a comprehensive, semi-structured interview measure with established validity and reliability used to identify and address a wide range of psychosocial problems in clinical populations. Average administration time for the GAIN Intake version is 1.5 hours and 45 minutes for the follow-up version. The assessment categories include background, school problems, work problems, physical health, sources of stress, risk behaviors and infectious diseases, mental health, substance use, and crime and violence. Substance use categories document self-reported frequency of substance use within the past 90 days for each substance endorsed (alcohol, opioids, marijuana, and other illicit psychoactive drugs). Individuals are able to say that they do not know, or refuse to answer any questions that they do not want to answer.
Proportion of opiates-negative urine drug screens over the total number of urine drug screens at each stage
时间窗: Each session (weekly) up to 24 weeks.
Qualitative urine test for opiates (+/-) will be performed. All presumptive positive assays will be confirmed by Gas Chromatography-Mass Spectrometry. The concentration value must be greater than or equal to the cutoff to be reported as positive. The opiates test results (positive/negative) will be documented. Proportion of opiates-negative urine drug screens over the total number of urine drug screens at each stage will be reported.
次要结局
- Completion of the final phase of treatment defined as final study session (yes/no)(24-week visit)
- Number of clinic visits by patient and any expected joint family member sessions(2-, 12, and 24-week visits.)
研究者
Justine Welsh
Assistant Professor
Emory University