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 27, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opioid Withdrawal | Drug: Pregabalin 200 MG capsules Drug: Placebo oral tablet Drug: Lofexidine 0.18Mg Tab | Phase 2 |
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 |

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
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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 |
- withdrawal [ Time Frame: 7 days ]reduction of withdrawal
- complete detoxification [ Time Frame: 7 days ]Proportion of subjects who complete the 7 day detoxification

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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:
- 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

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
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 |
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 |
Study Director: | Stuart Watson | Office of Research Administration, Univ. of Pennsylvania |
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 27, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Not at this time |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |