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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Clonidine; Lofexidine; Pregabalin

Criteria

Inclusion Criteria:

• Men and women 18+ years of age

• Meet Diagnostic and Statistical Manual- Fifth Edition (DSM-5) criteria for an Opioid Use Disorder with physiologic features

• Interested in opioid antagonist treatment

• Have used opioids in 20 of the past 30 days

• Have a stable address in the local area; not planning to move; have documents for identification 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 at screening. 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. If consultation is needed, the University of Pennsylvania cardiologists and the medical monitor should be consulted.

• For females, a negative pregnancy test, uses adequate contraception if of childbearing potential, does not engage in heterosexual behavior

Exclusion Criteria:

• Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features,) as defined by the Mini-International Neuropsychiatric Interview (MINI).

• Has an alcohol, benzodiazepine, or other sedative disorder with physiological features that requires medication for detoxification

• Has a 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 to the extent that immediate attention is required.

• High Risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on the Columbia Suicide Severity Rating Scale (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 if the subject can be included on a case-by-case basis.

• Heart rate and/or pulse <56bpm at screening-sitting

• Creatinine Clearance <60 mL/min

• Current seizure disorder (excluding childhood febrile seizures)

• Inability to read and/or understand English. For example, does not understand the informed consent as demonstrated by failing to correctly answer 9/10 questions on the quiz

• Pregnant or breastfeeding

• Currently taking antihypertensive medication, sympathomimetic drugs, or a thiazolidinedione antidiabetic (diuretics allowed)

• An ALT and/or AST that is at >3 times the top limit of normal

• History of cirrhosis or impaired renal function

• Currently receiving opioids for pain management

• Participated in a treatment study where medication was administered in the last 30 days.