- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04218240
Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal (PGB-LOF)
April 12, 2023 updated by: Kyle Kampman, University of Pennsylvania
Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?
A phase II double-blind placebo-controlled parallel group clinical trial that will randomize 90 subjects to investigate whether pregabalin (PGB) combined with Lofexidine (LFX) can reduce opioid withdrawal-related subjective effects, and investigate, whether the PGB/LFX combination can increase the proportion of patients with an opioid use disorder (OUD) who complete detoxification and transition to antagonist treatment with extended-release injectable naltrexone (XR-NTX).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An inpatient detoxification study where pregabalin (PBG) will be given orally at a starting dose of up to 600 mg daily (group 1) tapered to 100 mg daily over 7 days; given with lofexidine (LFX) starting at 2.16 mg daily and declining to 0.72 mg over 7 days.
On day 8, subjects are offered an injection of XR-NTX if they provide a urine sample that is negative for opioids and buprenorphine and pass a naloxone challenge.
All subjects, regardless of whether or not they receive XR-NTX, will be given a referral and appointment for follow-up treatment when they leave the inpatient detoxification program.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21229
- Mountain Manor Treatment Center
-
-
New York
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New York, New York, United States, 10019
- John Mariani
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Treatment Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male and/or female subjects ≥ 18 years of age
- Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have 2 or more of the 11 DSM 5 criteria for opioid disorder including tolerance and withdrawal features in the last 12 months
- Interested in opioid antagonist treatment
- Have used opioids in 20 or more of the last 30 days
- Have a stable address in the local area; not planning to move; have documents for ID check
- Absence of medical or psychiatric conditions that are likely to interfere with study participation
- Have a 12 lead ECG demonstrating a QTc ≤450 msec and a QRS interval ≤120 msec. The site PI has the final determination for inclusion into the study for ECGs unless there is a question of QT prolongation or other factors (QTc/Fre uses the Frederica formula (QTc = QT/RR(1/3)). If consultation is needed, the PENN cardiologists and the medical monitor should be contacted
- If female, have a negative pregnancy test and uses adequate contraception if of childbearing potential
Exclusion Criteria:
- Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features,) as defined by the MINI
- An alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
- History of allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
- Pending incarceration 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 at screening
- Blood pressure <90 mm Hg (systolic) or <60 mm Hg (diastolic). If this value is out of normal range, the investigator and a study clinician will decide subject inclusion or exclusion on a case-by-case basis
- Heart rate and/or pulse<50 bpm at screening-sitting
- An Estimated Glomerular Filtration Rate eGFR<90 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
- Pregnant or breastfeeding
- Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
- An ALT and/or AST test that is at >4X the top 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PGB/LFX;
0.54 mg lofexidine and 200 mg Pregabalin on days 1 -7 with taper for pregabalin and lofexidine starting on day 5
|
oral pregabalin 200 mg capsules given with a taper on day 5
Other Names:
lofexidine 0.18 tab given with a taper starting on day 5
Other Names:
|
Active Comparator: Lofexidine and PLACEBO
0.54 mg lofexidine and Placebo (PLB) on days 1-7 with taper for lofexidine starting on day 5
|
lofexidine 0.18 tab given with a taper starting on day 5
Other Names:
oral Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
withdrawal
Time Frame: 7 days
|
reduction of withdrawal
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete detoxification
Time Frame: 7 days
|
Proportion of subjects who complete the 7 day detoxification
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2020
Primary Completion (Actual)
March 23, 2023
Study Completion (Actual)
March 23, 2023
Study Registration Dates
First Submitted
January 2, 2020
First Submitted That Met QC Criteria
January 2, 2020
First Posted (Actual)
January 6, 2020
Study Record Updates
Last Update Posted (Actual)
April 14, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Substance Withdrawal Syndrome
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Narcotic Antagonists
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
- Lofexidine
Other Study ID Numbers
- 1UG3DA049694-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not at this time
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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