Phase 4 N=288 Randomized Treatment

Extended Release Naltrexone for Opioid-Dependent Youth

Drug Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01843023 ↗

Enrolled (actual)

288

Serious AEs

3.5%

Results posted

Nov 2021

Primary outcome: Primary: Opioid Use at 6 Month Follow-up — 19.63; 18.42 days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Extended Release Naltrexone (Drug); Psychosocial Treatment (Behavioral); Buprenorphine (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: All
Sponsor: Friends Research Institute, Inc.
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Opioid Use at 6 Month Follow-up	19.63; 18.42	—
SECONDARY Treatment Retention	5.53; 4.69	<0.05 sig
SECONDARY Monetized Healthcare Utilization	8136; 6629	—
SECONDARY HIV Sex Risk Behaviors	3.53; 3.42	<0.05 sig

Summary

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).

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01843023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.