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

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.

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.