Opioid Use Disorder
Research Study
The University of Pennsylvania Center for Studies of Addiction is studying an investigational medication to reduce opioid withdrawal-related effects.
Philadelphia, PA
Compensation
Provided
Able to stay 8 nights at hospital
Ongoing Opioid Use for Pain Management
18 Years and Older
Fast Facts
About this research study:
Help researchers learn more about reducing opioid withdrawal effects by participating in a compensated study of an investigational medication.
A combination of Pregabalin and Lofexidine medication is being tested to help patients detoxing from opioid use by reducing withdrawal effects such as achiness, feeling bad, anxiety, and insomnia.

We are looking for people who are currently regularly, using nonprescription opiates. This study involves taking investigational drugs to learn whether they can be used for the treatment of opioid use disorder and help to transition to other treatments.
Additional Information
Why is this study being done?
The purpose of the study is to learn whether pregabalin (LYRICA®) combined with lofexidine (LUCEMYRA®) can reduce opioid withdrawal-related effects when you are detoxing from your opioid use. In addition, we want to know if these medications can increase your chances of transitioning to other treatments.
Is this study for me?
You may qualify for this study if you meet the following criteria.

Inclusion Criteria:
  • You are a Male or Female
  • You are over the age of 18
  • Have used opioids in 20 of the past 30 days
  • Interested in treatment for your opioid usage
  • Have a stable address in the local area; not planning to move
  • Do not have severe medical or psychiatric conditions that are likely to interfere with study participation
  • For females: a negative pregnancy test, use of adequate contraception if of childbearing potential OR not engaging in heterosexual behavior
Exclusion Criteria:
  • Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features)
  • Have an alcohol, benzodiazepine, or other sedative disorder
  • Have a history of allergy or other serious reaction 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.Blood pressure ≤90 mm Hg (systolic) or ≤60 mm Hg (diastolic)
  • 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
  • Pregnant or breastfeeding
  • Currently taking antihypertensive medication, sympathomimetic drugs, or a thiazolidinedione antidiabetic (diuretics allowed)
  • 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
What will happen if I participate in the study?
This is a 15 day study involving blood draws and an in-person medical assessments. Included in those 15 days is a 8 to 9 day inpatient stay at our hospital.
Will I be paid for being in this research study?
Procedures are at no cost to you and you will be compensated for your participation.
Will it cost me anything to participate in this study?
There is no cost for you to participate in this study.