CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
CI-581aa +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02437344
NCT02437344Phase 2Completed

Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence

New York State Psychiatric Institute·interventional·Posted May 7, 2015·Updated Apr 8, 2019

In Brief

A Phase 2 clinical trial evaluating CI-581aa and Naltrexone titration and XR-NTX initiation for Opioid Dependence. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Opioid dependence is a substantial problem associated with significant morbidity and mortality. Extended-release naltrexone has been found effective at reducing opioid use and maintaining abstinence, but its use has been limited by the difficulties encountered with treatment initiation, which involves detoxification from opioids and oral naltrexone titration. Improving the likelihood of a successful transition to naltrexone is therefore an important public health goal. N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and symptoms of withdrawal from opioids, as well as to address adaptations associated with chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and ameliorating adaptations associated with drug dependence, such as craving and arousal. The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone initiation in opioid dependent individuals. After administration of extended-release naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care subsequently (oral naltrexone, extended-release naltrexone).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 7, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.2 years ago

Interventions

CI-581aadrug

92 minute infusion of CI-581aa

Naltrexone titration and XR-NTX initiationdrug

participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX