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
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring opioid use disorder, lofexidine, naltrexon-xr
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)
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
NCT ID
NCT04056182
First Posted
August 12, 2019
Last Updated
December 8, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
USWM, LLC (dba US WorldMeds)
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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