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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subjective Opioid Withdrawal Scale (SOWS) scores
Timeframe: 10 days per subject, through study completion (N=150)
. 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
. 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