Medication-Assisted Treatment for Youth With Substance Use Disorders
Condition: Opioid Use Disorder; Opioid Dependence
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this open-label pilot study is to determine the tolerability and applicability
      of outpatient long-acting injectable naltrexone (Vivitrol) treatment in individuals age 16-25
      ("older youth") with opioid use disorder. Outpatient treatment will consist of a 7-day
      outpatient detoxification / naltrexone induction procedure followed by 8-weeks of treatment
      with Vivitrol.
    

Detailed description: 
      The rates of opioid use in youth are rising. Long-acting injectable naltrexone (Vivitrol), a
      medication that blocks the effects of opioid drugs, has been shown to be effective for
      treatment of opioid dependence in adults. Vivitrol is an important option for individuals not
      wanting agonist treatment (e.g. buprenorphine, methadone). Vivitrol may be particularly
      appealing to youth who have difficulty reaching their opioid use goals with daily oral
      medications as it is a monthly injection and therefore eliminates the problem of daily
      medication non-adherence. Vivitrol may also be appealing to families as it reduces conflicts
      around issues of adherence and thus supports positive parenting. Whereas Vivitrol has been
      used clinically in minors, it has not been studied in a prospective outpatient trial.
      Starting naltrexone, however, can be challenging in opioid-dependent individuals because
      detoxification is required prior to treatment with this medication.There are no standard
      outpatient detoxification protocols for opioid-dependent youth. Therefore, more studies are
      needed to support broader and approved use of Vivitrol in this population.

      The purpose of this open-label pilot study is to determine the tolerability and applicability
      of outpatient long-acting injectable naltrexone (Vivitrol) treatment in individuals age 16-25
      ("older youth") with opioid use disorder. We aim to have 16 older youth complete this trial.
      Participants will undergo an outpatient detoxification / induction procedure that has been
      honed over the past 13 years of work with this medication by others in our Division and is
      currently being used safely in opioid-dependent adults in an ongoing clinical trial. The
      detoxification / induction procedure consists of a single day of buprenorphine followed by a
      washout day and 4 days of ascending oral naltrexone doses prior to administering a dose of
      injectable naltrexone, typically at Day 8. Participants will then receive an additional
      Vivitrol injection 4 weeks after the first; they will also receive weekly medication
      management therapy with a research psychiatrist. Following the 9 week trial, participants and
      are eligible for an additional third injection followed by up to 4 weeks of therapy while
      proper follow-up treatment is arranged.

      Primary Aim: To determine the tolerability and applicability of outpatient Vivitrol treatment
      in individuals aged 16-25 ("older youth") with opioid use disorder as determined by retention
      in treatment across the study. Outpatient treatment will consist of a 7-day detoxification /
      naltrexone induction procedure followed by 8-weeks of treatment with Vivitrol.

      Secondary Aim 1:To determine the tolerability of 7-day outpatient detoxification / naltrexone
      induction for older youth as assessed by retention through first administration of Vivitrol.

      Secondary Aim 2:To determine the tolerability of initial (4-week) treatment with Vivitrol as
      assessed by receipt of the second Vivitrol injection at week 4.

      Secondary Aim 3:To determine the safety and tolerability of Vivitrol treatment as assessed
      with measures of adverse events.
    

Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention description(s): Outpatient detoxification and induction onto long-acting naltrexone followed by an additional second injection of long-acting naltrexone and and additional third if desired.
Other intervention name(s): Long acting naltrexone; Vivitrol
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent; Youth