Status:
COMPLETED
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
USWM, LLC (dba US WorldMeds)
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 initi...
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. Lofexidin...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04056182
Start Date
September 1 2019
End Date
January 29 2021
Last Update
December 9 2021
Active Locations (1)
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1
STARS/NYSPI-Columbia University
New York, New York, United States, 10019