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Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

Primary Purpose

Opioid-use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lofexidine 0.18 MG
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring opioid use disorder, lofexidine, naltrexon-xr

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • STARS/NYSPI-Columbia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lofexidine

Arm Description

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.

Outcomes

Primary Outcome Measures

Successful Vivitrol Induction
number of participants inducted onto Vivitrol

Secondary Outcome Measures

Full Information

First Posted
August 12, 2019
Last Updated
December 8, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
USWM, LLC (dba US WorldMeds)
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1. Study Identification

Unique Protocol Identification Number
NCT04056182
Brief Title
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Official Title
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
January 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
USWM, LLC (dba US WorldMeds)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
opioid use disorder, lofexidine, naltrexon-xr

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open label treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lofexidine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lofexidine 0.18 MG
Other Intervention Name(s)
Lucemyra
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful Vivitrol Induction
Description
number of participants inducted onto Vivitrol
Time Frame
up to 10 days of detoxification and induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCES R (MD) R LEVIN, MD
Organizational Affiliation
New York Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
STARS/NYSPI-Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

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