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Facilitating Rapid Naltrexone Initiation

Primary Purpose

Opioid Dependence

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

CI-581-a

CI-581-b

About this trial

This is an interventional treatment trial for Opioid Dependence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids or a positive naloxone challenge test
Aged 18 to 70 years
In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges
Able to give written informed consent to participate in the study
Interested in maintenance treatment with extended-release naltrexone

Exclusion Criteria:

Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal requiring medical management
Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week); urine toxicology positive for methadone at admission
Buprenorphine maintenance treatment or regular use of buprenorphine (>16 mg per week); urine toxicology positive for buprenorphine at admission
Active, or past, psychiatric disorder(s) which might interfere with participation or make participation hazardous, including DSM-V mental disorder due to another medical condition, major depressive disorder, psychotic disorder, or bipolar disorder with psychotic features
Significant current suicidal risk or a suicide attempt within the past year
On psychotropic or other medications that may interact adversely with study medications, or whose effect might be disrupted by study medications
For women of childbearing potential: positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
Unstable physical disorders which might make participation hazardous such as hypertension (>160/90), anemia, active hepatitis or other liver disease (transaminase levels < 2-3 X the upper limit of normal will be considered acceptable), or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that the study medications in combination with this medication may increase the risk of drug-induced hepatitis
Acute hepatitis with SGOT or SGPT > 3 times the upper end of the laboratory normal range
Concurrent participation in another treatment study or another substance abuse program with the exception of a self-help group
History of allergy or sensitivity to any study medication
Ongoing chronic pain that may require opioid management, or for which surgery is indicated
History of inability to tolerate study medications
History of a use disorder with the study medications

Sites / Locations

New York State Psychiatric InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CI-581a

CI-581b

Arm Description

CI-581a will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated. (0.11 mg/kg 2-min bolus followed by 1.3 mg/kg over 90 min)

CI-581b will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated. (2-min saline bolus followed by 0.0125 mg/kg over 90 min)

Outcomes

Primary Outcome Measures

XR-NTX Initiation

Initiation of XR-NTX during the inpatient induction, without dropout or buprenorphine initiation.

Secondary Outcome Measures

Full Information

NCT ID

NCT03345173

First Posted

November 13, 2017

Last Updated

November 30, 2022

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03345173

Brief Title

Facilitating Rapid Naltrexone Initiation

Official Title

Glutamatergic Modulation to Facilitate Naltrexone Initiation: A Randomized, Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 25, 2017 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

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

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The incidence of opioid use disorders (OUDs) has increased to near-epidemic proportions. While maintenance with long-acting opioids such as methadone or buprenorphine represents an effective treatment strategy, it may be unacceptable to many individuals. As a result, long-acting injectable naltrexone (XR-NTX), an antagonist medication that blocks the effects of opioids for at least 4 weeks, is now indicated for relapse prevention following detoxification. This randomized, controlled trial aims to test the efficacy of a glutamate modulator at facilitating a rapid non-opioid based naltrexone induction.

Detailed Description

This study combines a nonopioid detoxification; a naltrexone titration schedule that allows for pushing the dose rapidly while monitoring closely to ensure tolerability; and infusions integrated into the treatment in such a way as to potentially ameliorate spontaneous and precipitated withdrawal. The first part of the treatment trial involves receiving inpatient treatment for up to 5 days. Following week 1, participants will meet with staff twice weekly and receive 12 weeks of mindfulness based relapse prevention and motivational interviewing sessions.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CI-581a

Arm Type

Experimental

Arm Description

Arm Title

CI-581b

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

CI-581-a

Intervention Description

Two infusions in the context of naltrexone induction protocol.

Intervention Type

Drug

Intervention Name(s)

CI-581-b

Intervention Description

Two infusions in the context of naltrexone induction protocol.

Primary Outcome Measure Information:

Title

XR-NTX Initiation

Description

Initiation of XR-NTX during the inpatient induction, without dropout or buprenorphine initiation.

Time Frame

From baseline to week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids or a positive naloxone challenge test Aged 18 to 70 years In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges Able to give written informed consent to participate in the study Interested in maintenance treatment with extended-release naltrexone Exclusion Criteria: Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal requiring medical management Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week); urine toxicology positive for methadone at admission Buprenorphine maintenance treatment or regular use of buprenorphine (>16 mg per week); urine toxicology positive for buprenorphine at admission Active, or past, psychiatric disorder(s) which might interfere with participation or make participation hazardous, including DSM-V mental disorder due to another medical condition, major depressive disorder, psychotic disorder, or bipolar disorder with psychotic features Significant current suicidal risk or a suicide attempt within the past year On psychotropic or other medications that may interact adversely with study medications, or whose effect might be disrupted by study medications For women of childbearing potential: positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control Unstable physical disorders which might make participation hazardous such as hypertension (>160/90), anemia, active hepatitis or other liver disease (transaminase levels < 2-3 X the upper limit of normal will be considered acceptable), or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that the study medications in combination with this medication may increase the risk of drug-induced hepatitis Acute hepatitis with SGOT or SGPT > 3 times the upper end of the laboratory normal range Concurrent participation in another treatment study or another substance abuse program with the exception of a self-help group History of allergy or sensitivity to any study medication Ongoing chronic pain that may require opioid management, or for which surgery is indicated History of inability to tolerate study medications History of a use disorder with the study medications

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elias Dakwar, MD

Phone

6467748728

elias.dakwar@nyspi.columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kate O'Malley, MA

Phone

6467746103

Kate.omalley@nyspi.columbia.edu

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elias Dakwar, M.D.

First Name & Middle Initial & Last Name & Degree

Elias Dakwar, M.D.

12. IPD Sharing Statement

Learn more about this trial

Facilitating Rapid Naltrexone Initiation

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