Facilitating Rapid Naltrexone Initiation

NCT03345173 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 75435R01DA042070-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (1)

• XR-NTX Initiation

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

  From baseline to week 12

Study Arms (2)

CI-581a

EXPERIMENTAL

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)

Drug: CI-581-a

CI-581b

PLACEBO COMPARATOR

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)

Drug: CI-581-b

Interventions

CI-581-a DRUG

Two infusions in the context of naltrexone induction protocol.

CI-581a

CI-581-b DRUG

Two infusions in the context of naltrexone induction protocol.

CI-581b

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elias Dakwar, MD

  NYSPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: November 25, 2017
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

US (1)