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Trial record 11 of 13 for:    buprenorphine | Recruiting Studies | United States | Phase 3, 4

Facilitating Rapid Naltrexone Initiation

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ClinicalTrials.gov Identifier: NCT03345173
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: CI-581-a Drug: CI-581-b Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glutamatergic Modulation to Facilitate Naltrexone Initiation: A Randomized, Controlled Trial
Actual Study Start Date : November 25, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

Drug: CI-581-a
Two infusions in the context of naltrexone induction protocol.

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)

Drug: CI-581-b
Two infusions in the context of naltrexone induction protocol.




Primary Outcome Measures :
  1. XR-NTX Initiation [ Time Frame: From baseline to week 12 ]
    Initiation of XR-NTX during the inpatient induction, without dropout or buprenorphine initiation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 (MINI, psychiatric exam)
  2. Aged 18 to 60 years (history)
  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 (psychiatric evaluation)
  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. (psych eval, MINI)
  2. Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week); urine toxicology positive for methadone at admission (psych eval, urine tox)
  3. Buprenorphine maintenance treatment or regular use of buprenorphine (>16 mg per week); urine toxicology positive for buprenorphine at admission (psych eval, urine tox)
  4. Active, or past, psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-V organic mental disorder, psychotic disorder, or bipolar disorder with mania (psych eval, MINI)
  5. Significant current suicidal risk or a suicide attempt within the past year (psych eval)
  6. On psychotropic or other medications that may interact adversely with study medications, or whose effect might be disrupted by study medications (psych/med eval, MINI)
  7. Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control (med eval, bloodwork)
  8. Uncontrolled neurological, cardiovascular, renal, and hepatic diseases, active tuberculosis, AIDS, or any other disorder that might make administration of study medications hazardous (med eval)
  9. Acute hepatitis with SGOT or SGPT > 3 times the upper end of the laboratory normal range (bloodwork)
  10. Concurrent participation in another treatment study or another substance abuse program with the exception of a self-help group (psych eval)
  11. History of allergy or sensitivity to any study medication (med eval)
  12. Ongoing chronic pain that may require opioid management, or for which surgery is indicated (med eval)
  13. History of inability to tolerate study medications (psych eval)
  14. History of ketamine use disorder (psych eval, MINI)
  15. Active major depressive disorder (psych eval, MINI)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345173


Contacts
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Contact: Elias Dakwar, MD 6467748728 elias.dakwar@nyspi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Elias Dakwar, M.D.         
Principal Investigator: Elias Dakwar, M.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)

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Responsible Party: Elias Dakwar, Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03345173     History of Changes
Other Study ID Numbers: 7543
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Ketamine
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action