Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

NCT04056182 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 7812
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Keywords

opioid use disorder; lofexidine; naltrexon-xr

Outcome Measures

Primary Outcomes (1)

• Successful Vivitrol Induction

  number of participants inducted onto Vivitrol

  up to 10 days of detoxification and induction

Study Arms (1)

Lofexidine

EXPERIMENTAL

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

Interventions

Lofexidine 0.18 MG 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.

Also known as: Lucemyra

Lofexidine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications (Clinical interview; psychiatrist)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• USWM, LLC (dba US WorldMeds): collaborator

Study Sites (1)

STARS/NYSPI-Columbia University

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

lofexidine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Frances R Levin, MD
• Organization: New York State Psychiatric Institute

frances.levin@nyspi.columbia.edu

6467746137

Study Officials

• FRANCES R (MD) R LEVIN, MD

  New York Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Model Details: open label treatment

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: September 1, 2019
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: December 9, 2021
• Results First Posted: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)