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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

Tracking Information
First Submitted Date  ICMJE April 26, 2015
First Posted Date  ICMJE May 7, 2015
Results First Submitted Date  ICMJE August 7, 2017
Results First Posted Date  ICMJE September 6, 2017
Last Update Posted Date April 8, 2019
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2015)
Successful Naltrexone Initiation [ Time Frame: 2 weeks ]
The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2015)
Withdrawal: Subjective Opioid Withdrawal Scale scores at baseline and administered subsequently [ Time Frame: 5 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
Official Title  ICMJE Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid Dependence
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: CI-581aa
CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing
Interventions:
  • Drug: CI-581aa
  • Drug: Naltrexone titration and XR-NTX initiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2016)
16
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2015)
8
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02437344
Other Study ID Numbers  ICMJE #7057
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elias Dakwar, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Elias Dakwar, MD NYSPI
PRS Account New York State Psychiatric Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP