Phase 2
N=20
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04056182 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Dec 2021
Primary outcome: Primary: Successful Vivitrol Induction — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lofexidine 0.18 MG (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Vivitrol Induction |
10 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04056182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.