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N/A N=82 Randomized Treatment

Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone

Opioid-use Disorder

Enrolled (actual)
82
Serious AEs
4.6%
Results posted
Sep 2023
Primary outcome: Primary: The Percentage of Patients Who Receive the First XR-NTX Injection (Dichotomous: Did or Did Not Receive First Dose of XR-NTX) — 68; 141 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Standard Induction Procedure (SP) (Other); Rapid Induction Procedure (RP) (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
New York State Psychiatric Institute
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
The Percentage of Patients Who Receive the First XR-NTX Injection (Dichotomous: Did or Did Not Receive First Dose of XR-NTX)
68; 141
SECONDARY
Mean for Time From Admission to First XR-NTX Injection by Treatment Group.
14.5; 7.0
SECONDARY
Mean of Individual Participant's Opioid Craving Measured by Visual Analog Scales (VAS) During Induction Phase
SECONDARY
Mean of Individual Participant's Opioid Craving Measured by Visual Analog Scales (VAS) During Post-induction Weeks 1 Through 8
SECONDARY
Mean of Individual Participant's Opioid Withdrawal Measured by Subjective Opioid Withdrawal Scale (SOWS) During Induction Phase
SECONDARY
Mean of Individual Participant's Opioid Withdrawal Measured by Subjective Opioid Withdrawal Scale (SOWS) During Post-induction Weeks 1 Through 4
SECONDARY
Mean of Individual Participant's Opioid Withdrawal Measured by Clinical Opioid Withdrawal Scale (COWS) During Induction Phase
SECONDARY
Mean of Individual Participant's Opioid Craving Measured by Clinical Opioid Withdrawal Scale (COWS) During Post-induction Weeks 1 Through 4
SECONDARY
Mean for Individual Participant's Patient Health Questionnaire (PHQ-9) Score During Induction Phase
SECONDARY
Mean for Individual Participant's Patient Health Questionnaire (PHQ-9) Score During Post-induction Weeks 1 Through 8
SECONDARY
Mean for Individual Participant's General Anxiety Disorder (GAD-7) Score During Induction Phase
SECONDARY
Mean for Individual Participant's General Anxiety Disorder (GAD-7) Score During Post-induction Weeks 1 Through 8
SECONDARY
Frequency of Targeted Safety Events Related to Study Medication and Any Serious Adverse Events During Induction Period and During Eight Weeks of Post-induction Treatment
SECONDARY
Number of Medical Visits and Therapy Completed During Follow up Treatment.
SECONDARY
Percent of Patients Reporting Continued Treatment With Medication for Opioid Use Disorder (MOUD) at Week 8
SECONDARY
Percent of Participants Positive for Opioids Using Weekly TLFB During Eight Weeks of Post-induction
SECONDARY
Percent of Participants Positive for Opioids Using Urine Drug Screens at Week 4 and 8
SECONDARY
Percent of Participants Positive for Cocaine, Sedatives, Alcohol, Cannabis, and Tobacco Using Weekly TLFB During Eight Weeks of Post- Induction
SECONDARY
Percent of Participants Positive for Cocaine, Sedatives, Alcohol, Cannabis, and Tobacco Using Urine Drug Screens at Week 4 and 8
SECONDARY
Proportion of Participants That Receive Second and Third Injection of XR-NTX (at 1 Month and 2 Months, From First Injection)

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 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.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04762537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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