Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone

Completed · Not applicable

Conditions studied: Opioid-use Disorder

In brief

This study compares two methods of initiating treatment with extended-release naltrexone (XR-NTX) when implemented at community-based inpatient or residential programs. The primary goal of this hybrid effectiveness-implementation study is to determine whether the Rapid Method (5-7 day long) is non-inferior to a Standard Method (13-day long) on the primary effectiveness outcome of successful initiation of XR-NTX (receiving the first injection). Secondary objectives include comparing Rapid versus Standard method on: time from admission to first dose of XR-NTX and time to dropout, craving, withdrawal severity, retention, abstinence, and safety measures, as measured during the inpatient induction process and the first two months of post-induction XR-NTX maintenance. Other exploratory outcomes include predictors of initiation success, and economic analyses. The implementation goal is to operationalize an implementation facilitation strategy that will be used to train clinical sites on the XR-NTX initiation method, to capture fidelity to the rapid induction process, and to study barriers and facilitators to implementation and refine the implementation facilitation strategy accordingly.

Key facts

Study ID

NCT04762537

Run by

New York State Psychiatric Institute

People needed

415

Starts

2021-03-16

Expected to finish

2022-12-21

Last updated by the study team

2023-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older.
• Meets current Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for opioid use disorder.
• Seeking treatment for opioid use disorder, willing to accept treatment with XR- NTX and, in the judgment of the treating physician, is a good candidate for naltrexone- based treatment.
• Willing and able to provide written informed consent.
• Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
• If female of childbearing potential, willing to practice an effective method of birth control for the duration of participation in the study.

You may not qualify if…

• Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make a detoxification and naltrexone initiation, or maintenance treatment with XR-NTX, hazardous (relative contra-indications) or requires a different level of care. Examples include:
• Disabling or terminal medical illness (e.g., uncompensated heart failure, severe acute hepatitis, cirrhosis or end-stage liver disease) as assessed by medical history and/or review of systems.
• Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview.
• Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included).
• Suicidal or homicidal ideation that requires immediate attention. Known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent.
• Maintenance treatment with methadone. 4. Maintenance treatment with buprenorphine unless the patient is determined to have a poor treatment response (in the form of buprenorphine non-adherence with or without the use of illicit opioids), warranting change to XR-NTX treatment.
• Presence of pain of sufficient severity as to require ongoing pain management with opioids.
• Circumstances (legal, personal, occupational) that would threaten the feasibility of XR- NTX treatment or make another treatment (e.g. buprenorphine or methadone) a better choice.
• Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
• If female, currently pregnant or breastfeeding, or planning on conception. 9. Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI>40, excess fat tissue over the buttocks, emaciation).
• Admitted to the inpatient detoxification or residential rehabilitation unit more than 3 days prior to consent.

Where it is running

• Aspire Health Partners — Orlando, Florida, United States
• Avery Road Treatment Center — Rockville, Maryland, United States
• Gibson Recovery Center, Inc. — Cape Girardeau, Missouri, United States
• Stony Brook Eastern Long Island Hospital — Greenport, New York, United States
• Adapt — Roseburg, Oregon, United States
• Nexus Recovery Center, Inc. — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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