A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
- Conditions
- Opioid Use Disorder
- Registration Number
- NCT04375033
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 952
Inclusion Criteria:<br><br> - Has used opioids within 30 days prior to consent or within 30 days prior to entry<br> into a supervised setting -- e.g., opioid use within the 30 days prior to recent<br> (<30 days) incarceration, entry into a detoxification facility, or entry into an<br> inpatient hospital setting<br><br> - Have started on MOUD via clinical induction on SL-BUP/NLX<br><br> - Meets DSM-5 criteria for moderate to severe OUD based on the Mini-International<br> Neuropsychiatric Interview<br><br> - Referred to/seeking treatment for OUD and willing to accept partial-agonist-based<br> therapy<br><br>Exclusion Criteria:<br><br> - Is a Veteran less than 18 years of age<br><br> - For Veterans of childbearing potential (a premenopausal person capable of becoming<br> pregnant), pregnancy, breastfeeding, and/or failure to practice an effective method<br> of birth control<br><br> - Taking a form of prescribed maintenance MOUD (e.g., methadone, buprenorphine or<br> XR-NTX) continuously >30 days prior to consent.<br><br> - Taking a form of prescribed maintenance MOUD (e.g., methadone, buprenorphine or<br> XR-NTX) continuously >45 days prior to randomization<br><br> - Has a history of significant adverse effects from buprenorphine and/or naloxone<br><br> - Has experienced (within the past 2 weeks) recent suicidal or homicidal ideation that<br> requires acute treatment or hospitalization.<br><br> - Is unwilling or unable to provide consent<br><br> - Meets criteria for current (past month) DSM-5 severe sedative hypnotic use disorder<br> based on the MINI SHUD module<br><br> - Is determined unsuitable for study participation based on the clinical judgement of<br> the LSI or Co-I given results of a CIWA-Ar, physical exam, and/or liver or kidney<br> function tests and/or blood tests<br><br> - Has any other medical, psychiatric, behavioral, or logistical condition which, in<br> the judgement of the LSI or Co-I, makes it unlikely the participant can participate<br> in or complete the 52-week active phase of the study<br><br> - Is actively participating in an interventional clinical trial for which a waiver of<br> dual-enrollment with CSP#2014 has not been obtained
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Retention in Treatment Change;Opioid Abstinence
- Secondary Outcome Measures
Name Time Method Accidental Opioid Poisoning (overdose);Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) seroconversion;Healthcare and Service Utilization;Other Addictive Substances;Opioid Craving;HIV Sexual and Injection Risk Behaviors;Patient Health Questionnaire (PHQ-9);PTSD Checklist for DSM-5;Texas Christian University Criminal Justice Form;Dental Quality of Life Questionnaire