Medication-Assisted Treatment for Youth With Substance Use Disorders

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Males or females 16-25 years of age

• If adult participant (>18 y/o), capacity to provide informed consent

• If minor participants (<18 y/o), capacity to assent

• If minor participants (<18 y/o), a legal guardian available to give informed consent and accompany minor participant to all appointments or formally designate another responsible adult to accompany the minor participant to the appointments subsequent to the initial visit.

• DSM-5 criteria for opioid use disorder as a primary diagnosis

• Psychiatrically stable

• Physically healthy

• Voluntarily seeking outpatient opioid antagonist treatment

• Able to perform study procedures

• English speaking

Exclusion Criteria:

• History of allergy intolerance or hypersensitivity to the study medications

• Meets DSM-5 criteria for substance use disorder other than opioid use disorder as the primary diagnosis (except nicotine or caffeine)

• Comorbid psychiatric disorder that might interfere with or make participation hazardous, including DSM-5 diagnosis of a psychotic disorder, severe major depressive disorder, or any psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or nonpharmacological intervention during the course of the study

• Pregnancy, lactation within the last 6 months, or failure to use effective contraceptive methods (condoms, diaphragm, birth control pill, IUD) in sexually active females

• Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week)

• Maintenance on, or regular use of, buprenorphine or other long-acting opioid agonists

• Current suicide risk or any suicide attempts within the past year

• Unstable medical conditions or laboratory test data, which might make participation hazardous, such as acute hepatitis or ALT or AST > 3 times normal

• History of accidental drug overdose in the last three years defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received

• Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications