Clinical trial NCT04056182: Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Official title: Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-use Disorder
Keywords: opioid use disorder
lofexidine
naltrexon-xr
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: USWM, LLC (dba US WorldMeds)
First posted: 2019-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label treatment
Primary purpose: TREATMENT

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.

Detailed 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.

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)

Primary outcomes:
measure: Successful Vivitrol Induction
timeFrame: up to 10 days of detoxification and induction
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: STARS/NYSPI-Columbia University
state: New York
Study officials:
affiliation: New York Psychiatric Institute
name: FRANCES R (MD) R LEVIN, MD
role: PRINCIPAL_INVESTIGATOR
References: