Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings

NCT02978417 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: Pro0007450769665
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent. Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and eligible clients of the Wake County Drug Court.

Conditions

Opioid-Related Disorders

Keywords

Medication-assisted treatment; Drug Court; Pilot study; Opioid dependence; Criminal justice

Outcome Measures

Primary Outcomes (2)

• Number of Participants With New Arrests

  Any new arrests during the 12-month study period. This information will be collected from administrative records.

  12 months

• Number of Participants With New Incarcerations

  Any new incarceration during the 12-month study period. This information will be collected from administrative records.

  12 months

Secondary Outcomes (13)

• Number of Positive Drug Screens

  12 months

• Number of Sanctions Imposed by the Court

  12 months

• Number of Missed Court Appointments

  12 months

• Vivitrol Participation

  12 months

• Treatment Participation (Non-Vivitrol)

  12 months

Study Arms (2)

Vivitrol

ACTIVE COMPARATOR

All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is naltrexone for extended-release injectable suspension. It is an injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).

Drug: Naltrexone for extended-release injectable suspension

Oral naltrexone

ACTIVE COMPARATOR

Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.

Drug: Oral naltrexone

Interventions

Naltrexone for extended-release injectable suspension DRUG

Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing.

Also known as: Vivitrol

Vivitrol

Oral naltrexone DRUG

Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.

Also known as: Revia

Oral naltrexone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Client of Wake County Drug Treatment Court
• Interested in medication-assisted treatment for opioid dependence
• years old
• understands and speaks English
• understands that study participation is fully voluntary, with no effect on court standing
• willing and able to give written informed consent
• has an opioid use disorder (DSM-5 diagnosis of moderate or severe opioid use disorder)
• has at least 6 months remaining before anticipated Drug Court graduation
• (if female) does not intend to become pregnant or breastfeeding during the study period and is willing to adhere to contraception requirements during the study period
• is willing to adhere to the study requirements
• Has at least 7-10 days without opioid use before beginning extended-release injectable naltrexone given that detoxification from opioids before initiating or resuming extended-release injectable naltrexone is necessary to prevent withdrawal.

You may not qualify if:

• Is pregnant (i.e., has a positive pregnancy test), planning to become pregnant, or breastfeeding during the study
• Has a positive urine drug test for opioids, buprenorphine or methadone at the beginning of treatment and before each Vivitrol® injection
• Has used any opioid drug within 10 days prior to treatment
• Has a condition, disease state, previous medical history, or observed abnormalities (including physical examination, laboratory evaluation \[e.g., kidney or liver function test result\], or urinalysis finding) at screening that, in the opinion of the investigator, would preclude safe participation in the study or affect the ability of the subject to adhere to the protocol visit schedule, fulfill visit requirements, or would interfere with the study assessments, including, but not limited to, the following:
• Uncontrolled hypertension, uncontrolled diabetes, renal disease/impairment, stroke, seizures or neurological disorder, cardiovascular (eg, endocarditis), neoplastic disease
• Chronic pain condition requiring ongoing opioid analgesia
• Aspartate aminotransferase or alanine aminotransferase value ≥3 times the upper limit of normal
• Any contraindicated medical condition per the approved labeling for naltrexone
• Has had a DSM-5 diagnosis within the past 12 months of other psychiatric conditions or disorders that, in the investigator's opinion, could interfere with participation in the study
• Is currently physiologically dependent on any psychoactive substance (except caffeine, or tobacco) requiring medical intervention for detoxification
• Has a history of hypersensitivity or adverse reaction to naltrexone, or naloxone
• Has had significant suicidal ideation or behavior within the past year, as assessed with the Patient Health Questionnaire (PHQ-9)

Sponsors & Collaborators

• Duke University: lead
• Laura and John Arnold Foundation: collaborator
• Alkermes, Inc.: collaborator
• FHR (Fellowship Health Resources, Inc.): collaborator
• Wake County Recovery Court: collaborator

Study Sites (1)

Fellowship Health Resources (FHR)

Raleigh, North Carolina, 27612, United States

Location

Related Links

• Vivitrol prescribing information

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexone; vivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Michele Easter, Ph.D.
• Organization: Duke University

michele.easter@duke.edu

919-385-0862

Study Officials

• Allison G Robertson, PhD, MPH

  Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 1, 2016
• Study Start: September 21, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)