Drug DependencePhase 4NCT01843023

Extended Release Naltrexone for Opioid-Dependent Youth

A Phase 4 study testing Extended Release Naltrexone, Psychosocial Treatment and Buprenorphine in people with Drug Dependence, run by Friends Research Institute, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 15 to 21 years
Conditions the study is for: Drug Dependence
What is being tested?: Extended Release Naltrexone, Psychosocial Treatment and Buprenorphine
Type of treatment: Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 2 sitesUnited States
Study dates: Jun 2013to Jul 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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);

Show all 9Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Friends Research Institute
Baltimore, Maryland, 21201
Mountain Manor Treatment Center
Baltimore, Maryland, 21229

Other trials in United States

About this study

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

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).

Read the detailed description

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.

Conditions: Drug Dependence
Being tested: Extended Release Naltrexone, Psychosocial Treatment, Buprenorphine
Keywords: opioid dependence
Medical subject headings: Substance-Related Disorders, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extended Release NaltrexoneDrug
Also called Vivitrol
naltrexone for extended release injectable suspension
Psychosocial TreatmentBehavioural
Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
BuprenorphineDrug
Also called Suboxone, Subutex
Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.

Study groups in NCT01843023
Study group	Role	What they receive
Extended Release Naltrexone	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. Receives: Drug: Extended Release Naltrexone; Behavioral: Psychosocial Treatment
Treatment as Usual	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. Receives: Behavioral: Psychosocial Treatment; Drug: Buprenorphine

What is being measured

The primary outcome is the main question the study is designed to answer.

Opioid Use at 6 Month Follow-up
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry.
Measured: 6 months

Secondary outcomes (3)

Treatment Retention
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of days in treatment. Treatment defined as medications for OUD received in past 30 days at 6-month follow-up.
Measured: 6 months
Monetized Healthcare Utilization
The cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization at 6 months.
Measured: 6 months
HIV Sex Risk Behaviors
To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months. Past 90 days self-reported HIV sex risk behaviors on the Risk Assessment Battery (RAB). Minimum value 0; maximum value 24. Higher scores reflect endorsement of more risk behaviors (worse outcome).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jul 2019

First posted30 Apr 2013 (estimated)
Study startJun 2013
Primary completion31 Jan 2018
Study completionJul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Drug DependenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01843023
Sponsor's protocol ID: 1R01DA033391-01A1
Other IDs: R01DA033391
Status last verified: Oct 2021
First submitted: 25 Apr 2013
Last updated: 10 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
fMRI and Opioid Abstinence
Drug Use Disorder, Opioid Dependence
RecruitingObservational study
Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder
Substance-Related Disorders, Drug Abuse
Recruiting
Neuroimaging of Adolescent Cannabis Use Treatment
Cannabis Use, Cannabis Dependence

All Drug Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth
ClinicalTrials.gov ID: NCT01843023
Acronym / sponsor ID: 1R01DA033391-01A1
Conditions: Drug Dependence
Keywords: opioid dependence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: Friends Research Institute, Inc.University, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jun 2013 (actual)
Primary completion: 31 Jan 2018 (actual)
Study completion: Jul 2019 (actual)
First posted: 30 Apr 2013 (estimated)
Results: Posted 10 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Extended Release Naltrexone	Experimental	Drug: Extended Release Naltrexone, Behavioral: Psychosocial TreatmentParticipants 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.
Treatment as Usual	Active comparator	Behavioral: Psychosocial Treatment, Drug: BuprenorphineParticipants 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.

Who may qualify

Ages: 15 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extended Release NaltrexoneAlso: Vivitrolnaltrexone for extended release injectable suspension	Drug	Extended Release Naltrexone
Psychosocial TreatmentPsychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.	Behavioural	Extended Release Naltrexone, Treatment as Usual
BuprenorphineAlso: Suboxone, SubutexParticipants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.	Drug	Treatment as Usual

Primary outcome

Opioid Use at 6 Month Follow-up
Time frame: 6 months
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry.

3 secondary outcomes

Treatment Retention
Time frame: 6 months
Monetized Healthcare Utilization
Time frame: 6 months
HIV Sex Risk Behaviors
Time frame: 6 months

Results and safety

Results posted to the registry on 10 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Extended Release Naltrexone	144	111
Treatment as Usual	144	109

Primary outcome: Opioid Use at 6 Month Follow-up

Time frame: 6 months. Mean (Standard Error). Unit: days

Measure	Extended Release Naltrexone n = 111	Treatment as Usual n = 109
Value	19.63 (2.55)	18.42 (2.68)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Extended Release Naltrexone	5 of 144 (3.5%)	132 of 144 (91.7%)	1 of 144
Treatment as Usual	5 of 144 (3.5%)	122 of 144 (84.7%)	0 of 144

Limitations and caveats (from the sponsor): There was poor participant adherence to receiving the randomly assigned condition prior to inpatient discharge. For this reason, great caution is urged in interpreting outcomes based on study condition as assigned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Drug Dependence

Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
fMRI and Opioid Abstinence
Drug Use Disorder, Opioid Dependence
RecruitingObservational study
Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder
Substance-Related Disorders, Drug Abuse
Recruiting
Neuroimaging of Adolescent Cannabis Use Treatment
Cannabis Use, Cannabis Dependence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shannon G Mitchell, PhD principal investigator

Friends Research Institute, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Extended Release Naltrexone, Psychosocial Treatment and Buprenorphine in people with Drug Dependence, run by Friends Research Institute, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Use at 6 Month Follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021; AzTrials last refreshed its copy on 26 Oct 2026.