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Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

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ClinicalTrials.gov Identifier: NCT04056182
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
US WorldMeds LLC
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

Brief Summary:
This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: Lofexidine 0.18 MG Phase 2

Detailed Description:
This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. Lofexidine is a nonopioid prescription medicine used in adults to help with the symptoms of opioid withdrawal that may happen when a person stops taking an opioid suddenly. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids. Lofexidine will be fixed-flexible dosing started on day 1 with maximum dose being three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals. Lofexidine treatment will continue throughout the detoxification, up to 10 days, and will be discontinued with a gradual dose reduction over 2 to 4 days. Precipitated withdrawal symptoms are treated with lofexidine, clonazepam, and other comfort medications. After the induction patients will be seen at the clinic for 8 weeks. Twice weekly for the first month and weekly for weeks 5-8. A second Vivitrol injection will be provided at week 4.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open label treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: Lofexidine
Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.
Drug: Lofexidine 0.18 MG
Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.
Other Name: Lucemyra




Primary Outcome Measures :
  1. Successful Vivitrol induction [ Time Frame: up to 10 days of detoxification and induction ]
    number of participants inducted onto Vivitrol



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:   No
Criteria

Inclusion Criteria:

  • Individuals between the ages of 18-60
  • Meets DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids on day of consent
  • Seeking treatment for opioid use disorder
  • Capable of giving informed consent and complying with study procedures
  • History of opioid withdrawal

Exclusion Criteria:

  • Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis
  • Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk
  • Methadone maintenance or long-acting agonist (buprenorphine) treatment -Buprenorphine maintenance treatment
  • Known history of allergy, intolerance, or hypersensitivity to candidate medication - - Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients
  • Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure >150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST and ALT >3 times the upper limit of normal)
  • Legally mandated to substance use disorder treatment
  • Currently physiological dependence on alcohol or sedative-hypnotics that would require a medically supervised detoxification-other substance use diagnoses are not exclusionary
  • Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications (Clinical interview; psychiatrist)

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): NCT04056182


Contacts
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Contact: Amy Mahony, LMHC 6467748183 amy.mahony@nyspi.columbia.edu
Contact: Daniel J Brooks, LMSW 6467748192 daniel.brooks@nyspi.columbia.edu

Locations
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United States, New York
STARS/NYSPI-Columbia University Recruiting
New York, New York, United States, 10019
Contact: Amy Mahony, LMHC    646-774-8183    amy.mahony@nyspi.columbia.edu   
Contact: Elizabeth Martinez    2129233031    elizabeth.martinez@nyspi.columbia.edu   
Principal Investigator: FRANCES LEVIN, MD         
Sponsors and Collaborators
Frances R Levin
US WorldMeds LLC
Investigators
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Principal Investigator: FRANCES R (MD) R LEVIN, MD New York Psychiatric Institute

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Responsible Party: Frances R Levin, Research Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT04056182     History of Changes
Other Study ID Numbers: 7812
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Frances R Levin, New York State Psychiatric Institute:
opioid use disorder
lofexidine
naltrexon-xr
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lofexidine
Clonidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Narcotic Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympatholytics
Autonomic Agents