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

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Alkermes, Inc.; Drug Treatment Court (Wake County, NC); FHR (Fellowship Health Resources, Inc.); Laura and John Arnold Foundation
• Treatments: Naltrexone

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)

• Note about exclusion criteria: If, after joining the study, a subject has a positive drug test, becomes pregnant, or acquires another exclusion condition that would have prevented him/her from joining the study, he or she may remain in the study but will not be permitted to receive Vivitrol®. Study staff will continue to gather interview data and administrative data on any enrolled, willing subjects.