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Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02437344
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : September 6, 2017
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Study Description
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Brief 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).


Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: CI-581aa Drug: Naltrexone titration and XR-NTX initiation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CI-581aa
CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing
 Drug: CI-581aa
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


Outcome Measures
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Primary Outcome Measures :
  1. Successful Naltrexone Initiation [ Time Frame: 2 weeks ]
    The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Active opioid dependence, with at least one positive utox result; no history of opioid overdose; and not currently using methadone or buprenorphine
  2. Physically healthy
  3. No adverse reactions to study medications
  4. 21-60 years of age
  5. Capacity to consent and comply with study procedures
  6. Seeking treatment

Exclusion Criteria:

  1. Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, and current substance-induced mood disorder with HAMD > 12.
  2. Physiological dependence on another substance requiring medical management, such as alcohol or benzodiazepines, excluding caffeine, nicotine, and cannabis
  3. Pregnant or interested in becoming pregnant
  4. Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
  5. Current suicide risk or a history of suicide attempt within the past 2 years
  6. On psychotropic or other medication whose effect could be disrupted by participation in the study
  7. Recent history of significant violence (past 2 years).
  8. Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
  9. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, active hepatitis or other liver disease (transaminase levels < 2 X the upper limit of normal will be considered acceptable), or untreated diabetes
  10. Previous history of CI-581 abuse, and/or a history of adverse reaction/experience wtih prior exposure to CI-581 or benzodiazepines
  11. BMI > 35, or a history of unmanaged obstructive sleep apnea
  12. First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)
  13. History of opioid overdose over the past 2 years requiring medical intervention
  14. Currently using methadone or buprenorphine
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Elias Dakwar, MD NYSPI
More Information
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Responsible Party: Elias Dakwar, Assistant Professor of Clinical Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02437344    
Other Study ID Numbers: #7057
First Posted: May 7, 2015    Key Record Dates
Results First Posted: September 6, 2017
Last Update Posted: April 8, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
 Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents