Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

Opioid-use Disorder Clinical Trial

Official title:

Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056182
• Other study ID #: 7812
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: January 29, 2021

Study information

• Verified date: December 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	STARS/NYSPI-Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	US WorldMeds LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Vivitrol Induction	number of participants inducted onto Vivitrol	up to 10 days of detoxification and induction