Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal

Completed · Phase 2 · Has a placebo group

Conditions studied: Opioid Withdrawal

In brief

A phase II double-blind placebo-controlled parallel group clinical trial that will randomize 90 subjects to investigate whether pregabalin (PGB) combined with Lofexidine (LFX) can reduce opioid withdrawal-related subjective effects, and investigate, whether the PGB/LFX combination can increase the proportion of patients with an opioid use disorder (OUD) who complete detoxification and transition to antagonist treatment with extended-release injectable naltrexone (XR-NTX).

Key facts

Study ID

NCT04218240

Run by

University of Pennsylvania

People needed

90

Starts

2020-12-17

Expected to finish

2023-08-31

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and/or female subjects ≥ 18 years of age
• Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have 2 or more of the 11 DSM 5 criteria for opioid disorder including tolerance and withdrawal features in the last 12 months
• Interested in opioid antagonist treatment
• Have used opioids in 20 or more of the last 30 days
• Have a stable address in the local area; not planning to move; have documents for ID check
• Absence of medical or psychiatric conditions that are likely to interfere with study participation
• Have a 12 lead ECG demonstrating a QTc ≤450 msec and a QRS interval ≤120 msec. The site PI has the final determination for inclusion into the study for ECGs unless there is a question of QT prolongation or other factors (QTc/Fre uses the Frederica formula (QTc = QT/RR(1/3)). If consultation is needed, the PENN cardiologists and the medical monitor should be contacted
• If female, have a negative pregnancy test and uses adequate contraception if of childbearing potential

You may not qualify if…

• Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features,) as defined by the MINI
• An alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
• History of allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
• Pending incarceration 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 at screening
• Blood pressure <90 mm Hg (systolic) or <60 mm Hg (diastolic). If this value is out of normal range, the investigator and a study clinician will decide subject inclusion or exclusion on a case-by-case basis
• Heart rate and/or pulse<50 bpm at screening-sitting
• An Estimated Glomerular Filtration Rate eGFR<90 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
• Pregnant or breastfeeding
• Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
• An ALT and/or AST test that is at >4X the top 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 it is running

• Mountain Manor Treatment Center — Baltimore, Maryland, United States
• John Mariani — New York, New York, United States
• Treatment Research Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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