Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence

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

• Study Type: Interventional
• Study Design: Allocation: N/A; 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	CI-581aa
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

Baseline Characteristics

Arm/Group Title		CI-581aa
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
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)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CI-581aa
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CI-581aa
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)

Adverse Events

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
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%)
Serious Adverse Events
	CI-581aa
	Affected / at Risk (%)
Total	0/16 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	CI-581aa
	Affected / at Risk (%)
Total	0/16 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: lsherma@nyspi.columbia.edu

• Responsible Party: Elias Dakwar, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02437344
• 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