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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid Dependence
Interventions Drug: CI-581aa
Drug: Naltrexone titration and XR-NTX initiation
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CI-581aa
Hide Arm/Group Description

CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing

CI-581aa: 92 minute infusion of CI-581aa

Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX

Period Title: Overall Study
Started 16
Completed 15
Not Completed 1
Arm/Group Title CI-581aa
Hide Arm/Group Description

CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing

CI-581aa: 92 minute infusion of CI-581aa

Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
37.8  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
4
  25.0%
Male
12
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  12.5%
White
14
  87.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
 100.0%
baseline opioid use (morphine equivalents)  
Mean (Standard Deviation)
Unit of measure:  Morphine eq, in mg
Number Analyzed 16 participants
297.7  (113.2)
1.Primary Outcome
Title Successful Naltrexone Initiation
Hide Description The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CI-581aa
Hide Arm/Group Description:

CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing

CI-581aa: 92 minute infusion of CI-581aa

Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
11
  91.7%
2.Secondary Outcome
Title Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CI-581aa
Hide Arm/Group Description:

CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing

CI-581aa: 92 minute infusion of CI-581aa

Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX

Overall Number of Participants Analyzed 12
Mean (Standard Error)
Unit of Measure: units on a scale
34  (7)
Time Frame 2 months, from treatment entry through the 1 month follow-up.
Adverse Event Reporting Description It does not differ.
 
Arm/Group Title CI-581aa
Hide Arm/Group Description

CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing

CI-581aa: 92 minute infusion of CI-581aa

Naltrexone titration and XR-NTX initiation: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX

All-Cause Mortality
CI-581aa
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CI-581aa
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CI-581aa
Affected / at Risk (%)
Total   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Linda Sherman
Organization: NYSPI
Phone: 6467747158
Responsible Party: Elias Dakwar, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02437344     History of Changes
Other Study ID Numbers: #7057
First Submitted: April 26, 2015
First Posted: May 7, 2015
Results First Submitted: August 7, 2017
Results First Posted: September 6, 2017
Last Update Posted: April 8, 2019