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Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal (PGB-LOF)

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ClinicalTrials.gov Identifier: NCT04218240
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Opioid Withdrawal Drug: Pregabalin 200 MG capsules Drug: Placebo oral tablet Drug: Lofexidine 0.18Mg Tab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: for the primary comparison of longitudinal subjective withdrawal measures, comparing the groups on rate of decrease across detox days, using a linear group by time effect for the mixed effects models described above. We have one primary outcome, so use an alpha level of 0.05, and we use two-sided tests. 90 subjects, 30 from each of three sites, who will be randomized into two groups, with 30 assigned to Lofexidine plus Placebo, and 60 to Lofexidine plus a starting daily dose of 400 mg of pregabalin and increasing to 600mg Pregabalin on day 2.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The Penn Investigational Drug Service (IDS) will prepare blinded pregabalin capsules by over encapsulation of the drug into capsules shells matching the placebo capsules. Blinded pregabalin capsules will be packaged into blister packs along with lofexidine tablets, in separate compartments that are labeled for dosing times on days 1-7 and ship them to the research sites.
Primary Purpose: Treatment
Official Title: Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?
Actual Study Start Date : December 20, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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
Drug: Pregabalin 200 MG capsules
oral pregabalin 200 mg capsules given with a taper on day 5
Other Name: lyrica

Drug: Lofexidine 0.18Mg Tab
lofexidine 0.18 tab given with a taper starting on day 5
Other Name: lucemyra

Active Comparator: Lofexidine and PLACEBO
0.54 mg lofexidine and Placebo (PLB) on days 1-7 with taper for lofexidine starting on day 5
Drug: Placebo oral tablet
oral Placebo

Drug: Lofexidine 0.18Mg Tab
lofexidine 0.18 tab given with a taper starting on day 5
Other Name: lucemyra




Primary Outcome Measures :
  1. withdrawal [ Time Frame: 7 days ]
    reduction of withdrawal


Secondary Outcome Measures :
  1. complete detoxification [ Time Frame: 7 days ]
    Proportion of subjects who complete the 7 day detoxification



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18+ years of age
  • Meet Diagnostic and Statistical Manual- Fifth Edition (DSM-5) criteria for an Opioid Use Disorder with physiologic features
  • Interested in opioid antagonist treatment
  • Have used opioids in 20 of the past 30 days
  • Have a stable address in the local area; not planning to move; have documents for identification 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 at screening. 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. If consultation is needed, the University of Pennsylvania cardiologists and the medical monitor should be consulted.
  • For females, a negative pregnancy test, uses adequate contraception if of childbearing potential, does not engage in heterosexual behavior

Exclusion Criteria:

  • Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features,) as defined by the Mini-International Neuropsychiatric Interview (MINI).
  • Has an alcohol, benzodiazepine, or other sedative disorder with physiological features that requires medication for detoxification
  • Has a 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 to the extent that immediate attention is required.
  • High Risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on the Columbia Suicide Severity Rating Scale (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 if the subject can be included on a case-by-case basis.
  • Heart rate and/or pulse <56bpm at screening-sitting
  • Creatinine Clearance <60 mL/min
  • Current seizure disorder (excluding childhood febrile seizures)
  • Inability to read and/or understand English. For example, does not understand the informed consent as demonstrated by failing to correctly answer 9/10 questions on the quiz
  • Pregnant or breastfeeding
  • Currently taking antihypertensive medication, sympathomimetic drugs, or a thiazolidinedione antidiabetic (diuretics allowed)
  • An ALT and/or AST that is at >3 times the top limit of normal
  • History of cirrhosis or impaired renal function
  • Currently receiving opioids for pain management
  • Participated in a treatment study where medication was administered in the last 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218240


Contacts
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Contact: kyle kampman, M.D. 215-746-2764 kampman@pennmedicine.upenn.edu
Contact: George E Woody, M.D. 325-746-7702 woodyg@pennmedicine.upenn.edu

Locations
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United States, Maryland
Mountain Manor Treatment Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Marc Fishman, MD    410-916-6839    mjfishman@comcast.net   
Contact: Kevin Wenzel, PhD    561-542-4282    kwenzel@mountainmanor.org   
United States, New York
John Mariani Active, not recruiting
New York, New York, United States, 10019
United States, Pennsylvania
Treatment Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kyle Kampman, M.D.    215-746-2764    kampman@pennmedicine.upenn.edu   
Contact: George Woody, M.D.    215-746-7702    woodyg@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Study Director: Stuart Watson Office of Research Administration, Univ. of Pennsylvania
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Responsible Party: Kyle Kampman, Professor Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04218240    
Other Study ID Numbers: 1UG3DA049694-01 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not at this time

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lofexidine
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antihypertensive Agents
Narcotic Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents