Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LFX/PGB, LFX/PLA-PGB.
- Who it may be relevant to
- Registry conditions: Opiate Withdrawal Syndrome, Opioid Use. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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. It follows a UG3 study in which 90 inpatients with an OUD who expressed interest in XR-NTX were randomized 2:1 to withdrawal management with lofexidine/pregabalin or lofexidine/placebo pregabalin. Results were that the conditions were equally safe, and that lofexidine/pregabalin was more effective in reducing subjective withdrawal and keeping patients in treatment than lofexidine/placebo pregabalin.
The objectives are to study the safety and effectiveness of lofexidine/pregabalin compared to lofexidine/placebo for managing opioid withdrawal and transitioning to XR-NTX in outpatient settings.
Interventions
- Drug LFX/PGB
lofexidine tablets 0.18mg tabs pregabalin capsules 100mg and 25mg - Drug LFX/PLA-PGB
lofexidine tablets 0.18mg tabs pregabalin capsules 0mg
Primary outcome measures
- Subjective Opioid Withdrawal Scale (SOWS) scores [Time frame: 10 days per subject, through study completion (N=150)]
Secondary outcome measures (2)
- Study detox completion [Time frame: 10 days per subject, through study completion (N=150)]
- XR-NTX IM injection [Time frame: upto 2 days per subject (N=150)]
Eligibility criteria
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
- Negative pregnancy test and using adequate contraception if of childbearing potential.
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
- An Estimated Glomerular Filtration Rate eGFR<70 mL/min/1.73m2
- A History of, or current Seizure disorder (excluding childhood febrile seizures)
- 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\. Pregnant or breastfeeding
- 13\. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
- ALT and/or AST >4X upper limit of normal
- A Child-Pugh score >7
- Currently receiving opioids for pain management
- In a treatment study where medication was administered in the last 30 days
- 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
- In a methadone maintenance or buprenorphine treatment program within the last 30 days
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Mountain Manor Treatment Center — Baltimore
- University of Pennsylvania, Treatment Research Center — Philadelphia
Identifiers
NCT: NCT05995535 · 854046