lofexidine for management of opioid withdrawal with xr-ntx treatment

Conditions: Opioid-use Disorder

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.

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.

Eligibility 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)

Keywords: opioid use disorder lofexidine naltrexon-xr