Opioid-use Disorder Clinical Trial
Official title:
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Verified date | December 2021 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | STARS/NYSPI-Columbia University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | US WorldMeds LLC |
United States,
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 |
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