Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: Naltrexone for extended-release injectable suspension; Oral naltrexone
Intervention description: 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.; 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 MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Medication-assisted treatment; Drug Court; Pilot study; Opioid dependence; Criminal justice

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.
    

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.