Back to resultsGlutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
Primary Purpose
Opioid Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CI-581aa
Naltrexone titration and XR-NTX initiation
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence
Eligibility Criteria
Inclusion Criteria:
- Active opioid dependence, with at least one positive utox result; no history of opioid overdose; and not currently using methadone or buprenorphine
- Physically healthy
- No adverse reactions to study medications
- 21-60 years of age
- Capacity to consent and comply with study procedures
- Seeking treatment
Exclusion Criteria:
- 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.
- Physiological dependence on another substance requiring medical management, such as alcohol or benzodiazepines, excluding caffeine, nicotine, and cannabis
- Pregnant or interested in becoming pregnant
- Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
- Current suicide risk or a history of suicide attempt within the past 2 years
- On psychotropic or other medication whose effect could be disrupted by participation in the study
- Recent history of significant violence (past 2 years).
- Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
- 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
- Previous history of CI-581 abuse, and/or a history of adverse reaction/experience wtih prior exposure to CI-581 or benzodiazepines
- BMI > 35, or a history of unmanaged obstructive sleep apnea
- First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)
- History of opioid overdose over the past 2 years requiring medical intervention
- Currently using methadone or buprenorphine
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CI-581aa
Arm Description
CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing
Outcomes
Primary Outcome Measures
Successful Naltrexone Initiation
The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX
Secondary Outcome Measures
Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently
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.
Full Information
NCT ID
NCT02437344
First Posted
April 26, 2015
Last Updated
April 3, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02437344
Brief Title
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
Official Title
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CI-581aa
Arm Type
Experimental
Arm Description
CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing
Intervention Type
Drug
Intervention Name(s)
CI-581aa
Other Intervention Name(s)
NMDA antagonist
Intervention Description
92 minute infusion of CI-581aa
Intervention Type
Drug
Intervention Name(s)
Naltrexone titration and XR-NTX initiation
Other Intervention Name(s)
naltrexone
Intervention Description
participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX
Primary Outcome Measure Information:
Title
Successful Naltrexone Initiation
Description
The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently
Description
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.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active opioid dependence, with at least one positive utox result; no history of opioid overdose; and not currently using methadone or buprenorphine
Physically healthy
No adverse reactions to study medications
21-60 years of age
Capacity to consent and comply with study procedures
Seeking treatment
Exclusion Criteria:
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.
Physiological dependence on another substance requiring medical management, such as alcohol or benzodiazepines, excluding caffeine, nicotine, and cannabis
Pregnant or interested in becoming pregnant
Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
Current suicide risk or a history of suicide attempt within the past 2 years
On psychotropic or other medication whose effect could be disrupted by participation in the study
Recent history of significant violence (past 2 years).
Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
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
Previous history of CI-581 abuse, and/or a history of adverse reaction/experience wtih prior exposure to CI-581 or benzodiazepines
BMI > 35, or a history of unmanaged obstructive sleep apnea
First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)
History of opioid overdose over the past 2 years requiring medical intervention
Currently using methadone or buprenorphine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Dakwar, MD
Organizational Affiliation
NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
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