NCT05995535 · University of Pennsylvania
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
(UH3)
What this study is about
A compared against an inactive treatment trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomly assigned 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.
View original scientific 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/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.
Interventions
DRUG
LFX/PGB
lofexidine tablets 0.18mg tabs pregabalin capsules 100mg and 25mg
DRUG
LFX/PLA-PGB
lofexidine tablets 0.18mg tabs pregabalin capsules 0mg
Primary outcome measures
Subjective Opioid Withdrawal Scale (SOWS) scores
Time frame: 10 days per subject, through study completion (N=150)
Subjective patient reported Opioid Withdrawal measured by the SOWS, (0-30); 0 = no withdrawal/30 = severe withdrawal
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Baltimore, Maryland
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations