Trial Outcomes & Findings for Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence (NCT NCT02437344)

NCT ID: NCT02437344

Last Updated: 2019-04-08

Results Overview

The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

2 weeks

Results posted on

2019-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	CI-581aa 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 Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CI-581aa n=16 Participants 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
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	37.8 years STANDARD_DEVIATION 12.3 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	14 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	16 Participants n=99 Participants
baseline opioid use (morphine equivalents)	297.7 morphine eq, in mg STANDARD_DEVIATION 113.2 • n=99 Participants

PRIMARY outcome

Timeframe: 2 weeks

The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX

Outcome measures

Outcome measures
Measure	CI-581aa n=12 Participants 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
Successful Naltrexone Initiation	11 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CI-581aa n=12 Participants 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
Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently	34 units on a scale Standard Error 7

Adverse Events

CI-581aa

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Linda Sherman

NYSPI

Phone: 6467747158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place