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

NCT ID: NCT02978417

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2019-06-30

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.

Detailed Description

Aim 1. Pilot RCT. The pilot delivery of Vivitrol® in the Wake County Drug Court will be carried out with 20-40 eligible drug court clients under treatment by Fellowship Health Resources, Inc. (FHR), the community behavioral health treatment agency that is the contracted treatment provider for the Wake County Drug Court. Participants will be randomized in equal number to receive Vivitrol® plus treatment as usual (TAU) or TAU only. TAU for drug court clients receiving services at FHR includes psychosocial treatment such as individual or group therapy, and sometimes also oral naltrexone for clients who are medically eligible and interested in taking the medication, the cost of which is covered by the agency for uninsured clients. (FHR currently administers Vivitrol® for a small number of interested agency clients with health insurance that covers the medication; the vast majority of their drug court clients are uninsured and so have no real access to the extended-release formulation due to its high cost.) Vivitrol® is an FDA-approved extended-release injectable form of naltrexone. Naltrexone is also available in oral, but not extended release, form. Naltrexone is an opioid antagonist that "blocks" opioid receptors in the brain to stop pleasurable feelings associated with taking opioids. Potentially eligible subjects will be drug court-referred FHR clients willing and eligible to take Vivitrol®, and willing to be randomly assigned to Vivitrol® or TAU. Potential subjects already under treatment with oral naltrexone at FHR would be eligible to enter the study if willing to switch to injectable Vivitrol® if randomly assigned. Study subjects who are randomized to Vivitrol® would receive a once-monthly injection of Vivitrol® for 12 months, or less if they decide to stop receiving Vivitrol® or to drop out of the study. Those randomized to TAU would continue with treatment as before, which could including (1) staying on oral naltrexone if already on it, (2) considering starting oral naltrexone, if interested, or (3) continuing with psychosocial treatment only. The Vivitrol® will be administered by study medical personnel at FHR. Randomization to the Vivitrol® arm would add urine pregnancy testing to FHR's existing Vivitrol® medical evaluation protocol and consent process, which currently screens for pregnancy without requiring a urine test. A urine pregnancy test will be administered once per month for female study participants of child-bearing age who are in the Vivitrol® group. All drug court clients, including study participants in both study groups, have urine drug tests at least once per week as part of program participation.

In addition to participating in Vivitrol® and psychosocial treatment, pilot RCT participants will provide consent for FHR and the drug court to share information with the study team about their demographic and clinical characteristics, treatment participation (e.g., outpatient group therapy), and court-related events (e.g., type of conviction that led to their drug court participation, missed drug court appointments, sanctions for program violations, and the results of drug screens).

Participants will also provide two face-to-face interviews at baseline and 6 months after baseline, about their interest and experience in Vivitrol® and/or other medication-assisted treatment (MAT), other treatment preferences, level of functioning, quality of life, and engagement in employment or education.

Outcome measures include treatment participation, compliance with drug court conditions, arrests and incarcerations, treatment satisfaction, and self-reported subjective measures of functioning and quality of life.

If a participant chooses not to participate in the study at any time, it will not affect his/her relationship with the court, FHR, right to health care, or participation in the study interview data collection. Site staff will follow participants for the purposes of collecting research and safety information. Investigators discontinue Vivitrol® or oral naltrexone in circumstances such as: adverse reactions to the medication; a change in medical status that makes it unsafe for a participant to continue receiving the medication, including pregnancy; or a participant becoming ill during the study. Participants who discontinue Vivitrol® or oral naltrexone for any reason may continue to participate in interviews for the study.

Conditions

Opioid-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Vivitrol

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).

Group Type: ACTIVE_COMPARATOR

Naltrexone for extended-release injectable suspension

Intervention Type: 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.

Oral naltrexone

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.

Group Type: ACTIVE_COMPARATOR

Oral naltrexone

Intervention Type: 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.

Interventions

Naltrexone for extended-release injectable suspension

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.

Intervention Type: DRUG

Oral naltrexone

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.

Intervention Type: DRUG

Other Intervention Names

Vivitrol; Revia

Eligibility Criteria

Inclusion Criteria

• Client of Wake County Drug Treatment Court
• Interested in medication-assisted treatment for opioid dependence
• 18-65 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laura and John Arnold Foundation

OTHER

Sponsor Role: collaborator

Alkermes, Inc.

INDUSTRY

Sponsor Role: collaborator

FHR (Fellowship Health Resources, Inc.)

OTHER

Sponsor Role: collaborator

Wake County Recovery Court

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison G Robertson, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Fellowship Health Resources (FHR)

Raleigh, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Related Links

http://www.Vivitrol.com/Content/pdf/prescribing_info.pdf

Vivitrol prescribing information

Other Identifiers

69665

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00074507

Identifier Type: -

Identifier Source: org_study_id