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Facilitating Rapid Naltrexone Initiation

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ClinicalTrials.gov Identifier: NCT03345173
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE November 13, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date March 22, 2021
Actual Study Start Date  ICMJE November 25, 2017
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
XR-NTX Initiation [ Time Frame: From baseline to week 12 ]
Initiation of XR-NTX during the inpatient induction, without dropout or buprenorphine initiation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Facilitating Rapid Naltrexone Initiation
Official Title  ICMJE Glutamatergic Modulation to Facilitate Naltrexone Initiation: A Randomized, Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Opioid Dependence
Intervention  ICMJE
  • Drug: CI-581-a
    Two infusions in the context of naltrexone induction protocol.
  • Drug: CI-581-b
    Two infusions in the context of naltrexone induction protocol.
Study Arms  ICMJE
  • Experimental: CI-581a

    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)

    Intervention: Drug: CI-581-a
  • Placebo Comparator: CI-581b

    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)

    Intervention: Drug: CI-581-b
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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
  2. Aged 18 to 70 years
  3. 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
  4. Able to give written informed consent to participate in the study
  5. Interested in maintenance treatment with extended-release naltrexone

Exclusion Criteria:

  1. Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal requiring medical management
  2. Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week); urine toxicology positive for methadone at admission
  3. Buprenorphine maintenance treatment or regular use of buprenorphine (>16 mg per week); urine toxicology positive for buprenorphine at admission
  4. 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
  5. Significant current suicidal risk or a suicide attempt within the past year
  6. On psychotropic or other medications that may interact adversely with study medications, or whose effect might be disrupted by study medications
  7. For women of childbearing potential: positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
  8. 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
  9. Acute hepatitis with SGOT or SGPT > 3 times the upper end of the laboratory normal range
  10. Concurrent participation in another treatment study or another substance abuse program with the exception of a self-help group
  11. History of allergy or sensitivity to any study medication
  12. Ongoing chronic pain that may require opioid management, or for which surgery is indicated
  13. History of inability to tolerate study medications
  14. History of a use disorder with the study medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elias Dakwar, MD 6467748728 elias.dakwar@nyspi.columbia.edu
Contact: Kate O'Malley, MA 6467746103 Kate.omalley@nyspi.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03345173
Other Study ID Numbers  ICMJE 7543
5R01DA042070-04 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elias Dakwar, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Elias Dakwar, MD NYSPI
PRS Account New York State Psychiatric Institute
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP