Extended Release Naltrexone for Opioid-Dependent Youth

Completed · Phase 4

Conditions studied: Drug Dependence

In brief

The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).

Key facts

Study ID

NCT01843023

Run by

Friends Research Institute, Inc.

People needed

288

Starts

2013-06-01

Expected to finish

2019-07-01

Last updated by the study team

2021-11-10

Who can join

Age: 15 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence, physiologic subtype;
• Within 3 days of admission to MMTC;
• Age between 15 and 21, inclusive;
• Able and willing to provide informed consent to be randomly assigned to XR- NTX or TAU; and for participants under 18 years of age, parental or guardian consent and participant assent.

You may not qualify if…

• Liver function test levels (Alanine Transaminase, Aspartate Transaminase) four times greater than normal;
• Unstable medical or psychiatric illness (e.g., schizophrenia) that might make participation hazardous;
• History of serious suicide attempt in the past 6 months;
• History of allergic reaction to naloxone, and/or naltrexone;
• Current chronic pain condition for which opioids are deemed necessary for ongoing care;
• blood coagulation disorder (e.g., hemophilia);
• Body Mass Index > 40;
• If female, pregnant, lactating, unwilling or unable (due to parental objection) to use FDA-approved contraceptive methods;
• meeting DSM-IV criteria for benzodiazepine dependence

Where it is running

• Friends Research Institute — Baltimore, Maryland, United States
• Mountain Manor Treatment Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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