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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04218240
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : January 27, 2022
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 : August 31, 2022
Estimated Study Completion Date : August 31, 2022

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Male and/or female subjects ≥ 18 years of age
  2. 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
  3. Interested in opioid antagonist treatment
  4. Have used opioids in 20 or more of the last 30 days
  5. Have a stable address in the local area; not planning to move; have documents for ID check
  6. Absence of medical or psychiatric conditions that are likely to interfere with study participation
  7. 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
  8. If female, have a negative pregnancy test and uses adequate contraception if of childbearing potential

Exclusion Criteria:

  1. Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features,) as defined by the MINI
  2. An alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
  3. History of allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
  4. Pending incarceration in the next 30 days
  5. Homicidal or otherwise behaviorally disturbed requiring immediate attention.
  6. High Risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on C-SSRS at screening
  7. 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
  8. Heart rate and/or pulse<50 bpm at screening-sitting
  9. An Estimated Glomerular Filtration Rate eGFR<90 mL/min/1.73m2
  10. A History of, or current Seizure disorder (excluding childhood febrile seizures)
  11. 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
  14. An ALT and/or AST test that is at >4X the top limit of normal
  15. A Child-Pugh score >7
  16. Currently receiving opioids for pain management
  17. In a treatment study where medication was administered in the last 30 days
  18. 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
  19. In a methadone maintenance or buprenorphine treatment program within 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 identifier (NCT number): NCT04218240

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Contact: kyle kampman, M.D. 215-746-2764
Contact: George E Woody, M.D. 325-746-7702

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United States, Maryland
Mountain Manor Treatment Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Marc Fishman, MD    410-916-6839   
Contact: Kevin Wenzel, PhD    561-542-4282   
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   
Contact: George Woody, M.D.    215-746-7702   
Sponsors and Collaborators
University of Pennsylvania
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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 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 27, 2022
Last Verified: January 2022
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
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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