MedTrace Logo

Facilitating Rapid Naltrexone Initiation

NCT03345173 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-02

No results posted yet for this study

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.

Conditions

  • Opioid Dependence

Interventions

DRUG

CI-581-a

Two infusions in the context of naltrexone induction protocol.

DRUG

CI-581-b

Two infusions in the context of naltrexone induction protocol.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Elias Dakwar, MD · NYSPI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-25
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345173 on ClinicalTrials.gov