Intervention: Naltrexone
Trial phase: Phase 4
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 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.

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.
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)

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.