Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
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|ClinicalTrials.gov Identifier: NCT02437344|
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : September 6, 2017
Last Update Posted : April 8, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Opioid Dependence||Drug: CI-581aa Drug: Naltrexone titration and XR-NTX initiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing
92 minute infusion of CI-581aa
Other Name: NMDA antagonist
Drug: Naltrexone titration and XR-NTX initiation
participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX
Other Name: naltrexone
- Successful Naltrexone Initiation [ Time Frame: 2 weeks ]The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX
- Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently [ Time Frame: 4 days ]Subjective Opioid Withdrawal Scale (SOWS) is a scale out of 64 points assessing withdrawal severity that is administered serially, every several hours, over the course of the naltrexone initiation. The questionnaire assesses symptoms that the patient rates on a scale of 0 (not at all) to 4 (extremely). The difference in total (sum) scores between baseline and end-of-induction will be reported. Scores range from 0 to 64.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437344
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Elias Dakwar, MD||NYSPI|