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Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

NCT ID: NCT04056182

Last Updated: 2021-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-01-29

Brief Summary

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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

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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.

Conditions

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Opioid-use Disorder

Keywords

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opioid use disorder lofexidine naltrexon-xr

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open label treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lofexidine 0.18 MG

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lucemyra

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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USWM, LLC (dba US WorldMeds)

INDUSTRY

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Frances R Levin

Research Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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FRANCES R (MD) R LEVIN, MD

Role: PRINCIPAL_INVESTIGATOR

New York Psychiatric Institute

Locations

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STARS/NYSPI-Columbia University

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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7812

Identifier Type: -

Identifier Source: org_study_id