Status:
RECRUITING
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
Lead Sponsor:
University of Pennsylvania
Conditions:
Opiate Withdrawal Syndrome
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pre...
Detailed Description
A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pre...
Eligibility Criteria
Inclusion
- Male and/or female subjects ≥ 18 years of age
- Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have met 2 or more of the 11 criteria for an OUD including tolerance and withdrawal within the last 12 months
- Interested in opioid antagonist treatment
- Used opioids in 20 or more of the last 30 days
- A stable address in the local area; not planning to move in the next 60 days.
- Have documents for ID check
- Absence of medical or psychiatric conditions that are likely to interfere with study participation
- Has 12 lead ECG demonstrating a QTc ≤450 msec and a QRS ≤120 msec. Site PI has final determination for study inclusion if readings exceed these limits. The PENN cardiologists and medical monitor are available for consultation when needed
- Negative pregnancy test and using adequate contraception if of childbearing potential.
Exclusion
- Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in remission
- Alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
- Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
- Pending incarceration or plans to leave the immediate area in the next 30 days
- Homicidal or otherwise behaviorally disturbed requiring immediate attention
- High risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on C-SSRS
- Blood pressure \<90 mm Hg (systolic) or \<60 mm Hg (diastolic). If value out of normal range, the investigator and study Clinician will decide subject inclusion/exclusion on case-by-case basis
- Heart rate and/or pulse\<50 bpm at screening-sitting
- An Estimated Glomerular Filtration Rate eGFR\<70 mL/min/1.73m2
- A History of, or current Seizure disorder (excluding childhood febrile seizures)
- Inability to read and/or understand English. For example, unable to understand the informed consent as demonstrated by failing to answer 9/10 questions correctly on the quiz
- 12\. Pregnant or breastfeeding
- 13\. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
- ALT and/or AST \>4X upper limit of normal
- A Child-Pugh score \>7
- Currently receiving opioids for pain management
- In a treatment study where medication was administered in the last 30 days
- Currently using medications that are known to be strong or moderate inhibitors of CYP2D6 such as fluoxetine, paroxetine, mirabegron, bupropion, quinidine, terbinafine, cimetidine, cinacalcet, duloxetine, or fluvoxamine
- In a methadone maintenance or buprenorphine treatment program within the last 30 days
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05995535
Start Date
January 1 2024
End Date
August 31 2026
Last Update
February 3 2025
Active Locations (2)
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1
Mountain Manor Treatment Center
Baltimore, Maryland, United States, 21229-3618
2
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104