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Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

NCT04056182 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-12-09

Study results available
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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.

Conditions

  • Opioid-use Disorder

Interventions

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.

Sponsors & Collaborators

  • USWM, LLC (dba US WorldMeds)

    collaborator INDUSTRY

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • FRANCES R (MD) R LEVIN, MD · New York Psychiatric Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-01-29
Completion
2021-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04056182 on ClinicalTrials.gov