Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal (NCT05995535) | Clinical Trial Compass
RecruitingPhase 2
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
United States150 participantsStarted 2024-01-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and/or female subjects ≥ 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 consultation when needed
Exclusion criteria
✕. 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
What they're measuring
1
Subjective Opioid Withdrawal Scale (SOWS) scores
Timeframe: 10 days per subject, through study completion (N=150)
✕. 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