Actively Recruiting
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
Led by University of Pennsylvania · Updated on 2026-02-13
150
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.
CONDITIONS
Official Title
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and/or female subjects 18 years of age or older
- Meet DSM-5 criteria for Opioid Use Disorder with physiologic features, including tolerance and withdrawal within the last 12 months
- Interested in opioid antagonist treatment
- Used opioids on 20 or more of the last 30 days
- Have a stable local address and not planning to move in the next 60 days
- Have documents for ID verification
- No medical or psychiatric conditions likely to interfere with participation
- 12 lead ECG showing QTc 450 msec and QRS 120 msec, with final inclusion decision by study investigator
- Negative pregnancy test and use of adequate contraception if able to become pregnant
You will not qualify if you...
- Current psychotic disorder such as bipolar I, schizophrenia, or major depression not in remission
- Alcohol, benzodiazepine, or sedative use disorder with physiological features requiring medication for detoxification
- Allergy or serious adverse reaction to pregabalin, XR-NTX, or lofexidine
- Pending incarceration or plans to leave the area in the next 30 days
- Homicidal or behaviorally disturbed requiring immediate attention
- High risk for suicide based on specific questionnaire responses
- Blood pressure below 90 mm Hg systolic or 60 mm Hg diastolic unless approved by investigator
- Heart rate or pulse below 50 bpm at screening
- Estimated Glomerular Filtration Rate below 70 mL/min/1.73m2
- History or current seizure disorder (excluding childhood febrile seizures)
- Inability to read or understand English demonstrated by consent quiz
- Pregnant or breastfeeding
- Currently taking sympathomimetic drugs or thiazolidinedione antidiabetics
- Elevated liver enzymes (ALT and/or AST more than 4 times upper limit)
- Child-Pugh score above 7
- Currently receiving opioids for pain management
- Participation in a medication treatment study within last 30 days
- Using medications that strongly or moderately inhibit CYP2D6
- Participation in methadone maintenance or buprenorphine treatment program within last 30 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Mountain Manor Treatment Center
Baltimore, Maryland, United States, 21229-3618
Not Yet Recruiting
2
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
K
Kyle M Kampman, MD
CONTACT
M
Matthew R Taylor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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