Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

• Status: Completed
• Trial end date: 2021-01-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Frances R Levin
• Collaborator: US WorldMeds LLC
• Treatments: Analgesics, Opioid; Clonidine; Lofexidine

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)