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Facilitating Rapid Naltrexone Initiation | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Facilitating Rapid Naltrexone Initiation

Glutamatergic Modulation to Facilitate Naltrexone Initiation: A Randomized, Controlled Trial

NCT03345173•New York State Psychiatric Institute

Summary

The incidence of opioid use disorders (OUDs) has increased to near-epidemic proportions. While maintenance with long-acting opioids such as methadone or buprenorphine represents an effective treatment strategy, it may be unacceptable to many individuals. As a result, long-acting injectable naltrexone (XR-NTX), an antagonist medication that blocks the effects of opioids for at least 4 weeks, is now indicated for relapse prevention following detoxification. This randomized, controlled trial aims to test the efficacy of a glutamate modulator at facilitating a rapid non-opioid based naltrexone induction.

Detailed Description

This study combines a nonopioid detoxification; a naltrexone titration schedule that allows for pushing the dose rapidly while monitoring closely to ensure tolerability; and infusions integrated into the treatment in such a way as to potentially ameliorate spontaneous and precipitated withdrawal. The first part of the treatment trial involves receiving inpatient treatment for up to 5 days. Following week 1, participants will meet with staff twice weekly and receive 12 weeks of mindfulness based relapse prevention and motivational interviewing sessions.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids or a positive naloxone challenge test
•2. Aged 18 to 70 years
•3. In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges
•4. Able to give written informed consent to participate in the study
•5. Interested in maintenance treatment with extended-release naltrexone

Exclusion Criteria

•1. Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal requiring medical management
•2. Methadone maintenance treatment or regular use of illicit methadone (\>30 mg per week); urine toxicology positive for methadone at admission
•3. Buprenorphine maintenance treatment or regular use of buprenorphine (\>16 mg per week); urine toxicology positive for buprenorphine at admission
•4. Active, or past, psychiatric disorder(s) which might interfere with participation or make participation hazardous, including DSM-V mental disorder due to another medical condition, major depressive disorder, psychotic disorder, or bipolar disorder with psychotic features
•5. Significant current suicidal risk or a suicide attempt within the past year
•6. On psychotropic or other medications that may interact adversely with study medications, or whose effect might be disrupted by study medications
•7. For women of childbearing potential: positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
•8. Unstable physical disorders which might make participation hazardous such as hypertension (\>160/90), anemia, active hepatitis or other liver disease (transaminase levels \< 2-3 X the upper limit of normal will be considered acceptable), or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that the study medications in combination with this medication may increase the risk of drug-induced hepatitis
•9. Acute hepatitis with SGOT or SGPT \> 3 times the upper end of the laboratory normal range
•10. Concurrent participation in another treatment study or another substance abuse program with the exception of a self-help group
+4 more criteria

Locations (1)

New York State Psychiatric Institute

New York, New York, United States

Key Dates

Start Date

November 25, 2017

Primary Completion Date

October 1, 2024

Completion Date

October 1, 2024

Last Updated

February 2, 2024

Enrollment

100

ESTIMATED participants

Conditions

Opioid Dependence

Interventions

CI-581-a

DRUG

CI-581-b

DRUG

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Opioid UseOpioid Dependence+9 more

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TERMINATEDPHASE2

Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder

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Opioid Dependence

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Facilitating Rapid Naltrexone Initiation

Inclusion Criteria

Exclusion Criteria

Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure

Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder

tDCS to Decrease Opioid Relapse (UG3)

Evaluation of Pain Neuroscience Education for Patients Who Experience Chronic Pain With Concurrent Opioid Dependence

A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.

Collaborative Care for Opioid Dependence And Pain Pilot Study