Status:
COMPLETED
Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
The overarching objective of the SWIFT trial (CTN-0097) is to foster widespread adoption of a regimen for rapid initiation of treatment with extended-release injection naltrexone (XR-NTX) at inpatient...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. 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.
- 3\. 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.
- 5\. Presence of pain of sufficient severity as to require ongoing pain management with opioids.
- 6\. 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.
- 7\. 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.
- 8\. 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).
- 10\. Admitted to the inpatient detoxification or residential rehabilitation unit more than 3 days prior to consent.
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT04762537
Start Date
March 16 2021
End Date
December 21 2022
Last Update
September 18 2023
Active Locations (6)
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1
Aspire Health Partners
Orlando, Florida, United States, 32810
2
Avery Road Treatment Center
Rockville, Maryland, United States, 20853
3
Gibson Recovery Center, Inc.
Cape Girardeau, Missouri, United States, 63703
4
Stony Brook Eastern Long Island Hospital
Greenport, New York, United States, 11944