Medication-Assisted Treatment for Youth With Substance Use Disorders

NCT02593474 | Completed Phase 1 DMC

• 2 other identifiers: #7146U54DA037842
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Opioid Use Disorder; Opioid Dependence

Keywords

Adolescent; Youth

Outcome Measures

Primary Outcomes (1)

• Retention in treatment at week 9 - the end of the study (this includes 1wk detox and 8 wks of treatment with Vivitrol)

  9 weeks

Secondary Outcomes (1)

• Retention through first administration of Vivitrol (ie number that receive first injection)

  7 days

Study Arms (1)

Detoxification / induction

OTHER

The detoxification / induction procedure consists of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses. Followed on day 8 by Vivitrol injection. Participants then receive a second injection 4 weeks after the first.

Drug: Naltrexone

Interventions

Naltrexone DRUG

Outpatient detoxification and induction onto long-acting naltrexone followed by an additional second injection of long-acting naltrexone and and additional third if desired.

Also known as: Long acting naltrexone, Vivitrol

Detoxification / induction

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

New York State Psychiatric Insitute

New York, New York, 10032, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexone; vivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Elizabeth Evans, MD

  Columbia University / New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: November 2, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (2)