Clinical Trials Logo

Clinical Trial 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02437344
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 2
Start date January 2015
Completion date December 2016

See also
  Status Clinical Trial Phase
Recruiting NCT03675386 - Reducing Opioid Use for Chronic Pain Patients Following Surgery N/A
Completed NCT02593474 - Medication-Assisted Treatment for Youth With Substance Use Disorders Phase 1
Completed NCT02294253 - Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone Phase 2/Phase 3
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT01592461 - Starting Treatment With Agonist Replacement Therapies Follow-up Study N/A
Terminated NCT00768482 - A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence Phase 3
Completed NCT01741350 - Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users N/A
Terminated NCT04121546 - Collaborative Care for Opioid Dependence And Pain Pilot Study N/A
Withdrawn NCT03368794 - Naloxone to TReatment Entry in the Emergency Setting N/A
Completed NCT03447743 - Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder Early Phase 1
Completed NCT04464421 - SMART Effectiveness Trial N/A
Recruiting NCT04189523 - Does Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures Effect Long Term Patient Opioid Usage N/A
Completed NCT03305666 - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures Phase 4
Recruiting NCT04003948 - Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification Phase 2
Not yet recruiting NCT03813095 - Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction Phase 2
Terminated NCT02935101 - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants Phase 2
Completed NCT01895270 - Improving Buprenorphine Detoxification Outcomes With Isradipine Phase 1/Phase 2
Completed NCT01717963 - Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway Phase 3
Completed NCT02324725 - Biomarkers of Injectable Extended Release Naltrexone Treatment Phase 4
Completed NCT01425060 - Improving Effective Contraceptive Use Among Opioid-maintained Women Phase 1