Opioid Use Clinical Trial
— UH3Official title:
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | August 31, 2026 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male and/or female subjects = 18 years of age 2. 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 3. Interested in opioid antagonist treatment 4. Used opioids in 20 or more of the last 30 days 5. A stable address in the local area; not planning to move in the next 60 days. 6. Have documents for ID check 7. Absence of medical or psychiatric conditions that are likely to interfere with study participation 8. 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 9. Negative pregnancy test and using adequate contraception if of childbearing potential. Exclusion Criteria: 1. Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in remission 2. Alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification 3. Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine 4. Pending incarceration or plans to leave the immediate area in the next 30 days 5. Homicidal or otherwise behaviorally disturbed requiring immediate attention 6. High risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on C-SSRS 7. 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 8. Heart rate and/or pulse<50 bpm at screening-sitting 9. An Estimated Glomerular Filtration Rate eGFR<70 mL/min/1.73m2 10. A History of, or current Seizure disorder (excluding childhood febrile seizures) 11. 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. 12. Pregnant or breastfeeding 13. 13. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic 14. ALT and/or AST >4X upper limit of normal 15. A Child-Pugh score >7 16. Currently receiving opioids for pain management 17. In a treatment study where medication was administered in the last 30 days 18. 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 19. In a methadone maintenance or buprenorphine treatment program within the last 30 days |
Country | Name | City | State |
---|---|---|---|
United States | Mountain Manor Treatment Center | Baltimore | Maryland |
United States | University of Pennsylvania, Treatment Research Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective Opioid Withdrawal Scale (SOWS) scores | Subjective patient reported Opioid Withdrawal measured by the SOWS, (0-30); 0 = no withdrawal/30 = severe withdrawal | 10 days per subject, through study completion (N=150) | |
Secondary | Study detox completion | Proportion that receives one or more doses of study medication and completed withdrawal (Completing withdrawal management will be defined as having received at least 1 dose of study medication on day 8 and completing the SOWS-Gossop assessment on day 8); and proportion that transition to XR-NTX; adverse events | 10 days per subject, through study completion (N=150) | |
Secondary | XR-NTX IM injection | proportion that receives 380mg dose of extended-release naltrexone | upto 2 days per subject (N=150) |
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