RECRUITING

Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

Quick Facts

Study Start:2024-01-01

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05995535

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 met 2 or more of the 11 criteria for an OUD including tolerance and withdrawal within the last 12 months 3. Interested in opioid antagonist treatment 4. Used opioids in 20 or more of the last 30 days 5. A stable address in the local area; not planning to move in the next 60 days. 6. Have documents for ID check 7. Absence of medical or psychiatric conditions that are likely to interfere with study participation 8. 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 9. Negative pregnancy test and using adequate contraception if of childbearing potential.	1. Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in remission 2. Alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification 3. Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine 4. Pending incarceration or plans to leave the immediate area 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 7. 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 8. Heart rate and/or pulse\<50 bpm at screening-sitting 9. An Estimated Glomerular Filtration Rate eGFR\<70 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. 12. Pregnant or breastfeeding 13. 13. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic 14. ALT and/or AST \>4X upper 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

Inclusion Criteria

Exclusion 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 met 2 or more of the 11 criteria for an OUD including tolerance and withdrawal within the last 12 months
3. Interested in opioid antagonist treatment
4. Used opioids in 20 or more of the last 30 days
5. A stable address in the local area; not planning to move in the next 60 days.
6. Have documents for ID check
7. Absence of medical or psychiatric conditions that are likely to interfere with study participation
8. 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
9. Negative pregnancy test and using adequate contraception if of childbearing potential.

1. Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in remission
2. Alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
3. Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
4. Pending incarceration or plans to leave the immediate area 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
7. 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
8. Heart rate and/or pulse\<50 bpm at screening-sitting
9. An Estimated Glomerular Filtration Rate eGFR\<70 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. 12. Pregnant or breastfeeding
13. 13. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
14. ALT and/or AST \>4X upper 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

Contacts and Locations

Study Contact

Kyle M Kampman, MD

CONTACT

215-746-2764

Kampman@pennmedicine.upenn.edu

Matthew R Taylor

CONTACT

215-746-0467

matthew.taylor@pennmedicine.upenn.edu

Study Locations (Sites)

Mountain Manor Treatment Center

Baltimore, Maryland, 21229-3618

United States

University of Pennsylvania, Treatment Research Center

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

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 Registration Dates

Study Start Date2024-01-01

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

Opiate Withdrawal Syndrome
Opioid Use