Supporting Treatment Access and Recovery in COD
- Conditions
- Opioid Use DisorderMental Health Disorder
- Registration Number
- NCT05138614
- Lead Sponsor
- University of Massachusetts, Worcester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria:<br><br> - Are 18 years-old and older;<br><br> - Are fluent in English or Spanish;<br><br> - Have OUD who (a) are newly admitted into the program with OUD; or (b) who have been<br> active in the program for the treatment of OUD with medications like buprenorphine<br> or naltrexone, but experienced a recent relapse with any substance (e.g., alcohol,<br> cocaine, opioids, or benzodiazepines). This second group is necessary to include<br> because patients who may have been stable for a long period of time may have a<br> relapse and need intensive treatment to help them regain their abstinence and<br> facilitate the path towards recovery. Thus, by taking those newly enrolled and those<br> who were stable on MOUD but had a recent relapse, the second group is clinically<br> similar to the first group and the intervention will be meaningful.;<br><br> - Able to provide consent;<br><br> - Potentially have a concurrent substance use disorder in addition to opioids; and<br><br> - Have a co-occurring mental health disorder (COD) including depression, anxiety,<br> trauma-related disorders, bipolar, and/or schizophrenia, and those who are stable on<br> buprenorphine or naltrexone but have recurrence or worsening at any time of symptoms<br> of any co-occurring mental health disorder (COD) including depression, anxiety,<br> trauma-related disorders, bipolar, and/or schizophrenia, even if the patient has not<br> relapsed. Instability is defined in two ways in the study: (a) a substance use<br> relapse; and (b) recurrence to symptom exacerbation in regard to a subject's mental<br> health disorder(s). If subjects do not meet criteria for a (i.e., not having a<br> substance use relapse), but they do meet criteria for b (i.e., they do in fact<br> have worsening of mental health symptoms), they are then defined as unstable, and<br> will meet study inclusion criteria.<br><br>Exclusion Criteria:<br><br> - Are not fluent in English or Spanish;<br><br> - Are acutely psychotic, acutely suicidal with a plan, or homicidal;<br><br> - Are incompetent and unable to provide informed consent; and<br><br> - Have concurrent severe alcohol use disorder or high dose benzodiazepine needing<br> detoxification. This exclusion factor is based on DSM-5 criteria, and those who are<br> currently drinking or with a history of severe alcohol withdrawal (i.e., alcohol<br> related seizures, and delirium tremens) will also be excluded. High dose<br> benzodiazepine is defined as using Lorazepam equivalent of > 10 mg/day; Diazepam ><br> 100 mg/day; Clonazepam 5 mg/ day; Alprazolam 5 mg/day.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method