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New treatment option for Opiate Withdrawal Syndrome
Official title Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
ClinicalTrials.gov ID: NCT05995535
What this study is testing
What is LFX/PGB?
LFX/PGB is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for opiate withdrawal syndrome.
Also referred to as Lucemyra, lyrica.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Male and/or female people ≥ 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...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- Male and/or female people ≥ 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...
- Negative pregnancy test and using adequate contraception if of childbearing potential.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Philadelphia, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.