Completed

Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Extended Release Naltrexone

+ Psychosocial Treatment

+ Psychosocial Treatment

DrugBehavioral
Who is being recruted

Narcotic-Related Disorders+2

+ Mental Disorders

+ Chemically-Induced Disorders

From 15 to 21 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorFriends Research Institute, Inc.
Last updated: November 10, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

This proposed study is a 6-month, two-group randomized clinical trial of XR-NTX v. TAU for 340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor Treatment Center, a community drug treatment program in Baltimore. TAU will consist of buprenorphine treatment of opioid withdrawal followed by counseling with or without continued buprenorphine.

NCT01843023
Principal SponsorFriends Research Institute, Inc.
Last updated: November 10, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

288 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Narcotic-Related DisordersMental DisordersChemically-Induced DisordersOpioid-Related DisordersSubstance-Related Disorders

Criteria

4 inclusion criteria required to participate
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
Age between 15 and 21, inclusive
Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence, physiologic subtype
Within 3 days of admission to MMTC
9 exclusion criteria prevent from participating
Body Mass Index > 40
Current chronic pain condition for which opioids are deemed necessary for ongoing care
History of allergic reaction to naloxone, and/or naltrexone
History of serious suicide attempt in the past 6 months
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.

Group II

Active Comparator
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Friends Research Institute

Baltimore, United StatesOpen Friends Research Institute in Google Maps

Mountain Manor Treatment Center

Baltimore, United States
Completed2 Study Centers