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NCT04218240 · ClinicalTrials.gov registry record · Phase 2
Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal
A Phase 2 study of Opioid Withdrawal, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 3
- Study locations
NCT04218240 is a Phase 2 study of Opioid Withdrawal that has completed, run by University of Pennsylvania. The registered enrollment target is 90 participants, below the 115-participant average among 9 other Opioid Withdrawal trials with a reported enrollment target (22% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT04218240, a Phase 2 study of Opioid Withdrawal, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 3
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Placebo oral tablet
- DRUG Pregabalin 200 MG capsules
- DRUG Lofexidine 0.18Mg Tab
Study Locations (3)
Maryland
- Mountain Manor Treatment Center - Baltimore
New York
- John Mariani - New York
Pennsylvania
- Treatment Research Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2023-08-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04218240
The ClinicalTrials.gov registry entry for NCT04218240 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 115-participant average among 9 other Opioid Withdrawal trials with a reported enrollment target (22% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Opioid Withdrawal appearing as the primary indexed condition, and to 3 interventions - of which Placebo oral tablet is the first listed.
NCT04218240 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Maryland, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04218240 about?
NCT04218240 is a clinical study titled "Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal". 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 p...
What is the current status of trial NCT04218240?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2020-12-17. Estimated completion is 2023-08-31.
What conditions does trial NCT04218240 study?
This clinical trial studies the following conditions: Opioid Withdrawal.
What interventions are being tested in trial NCT04218240?
The interventions under investigation include: Placebo oral tablet (DRUG), Pregabalin 200 MG capsules (DRUG), Lofexidine 0.18Mg Tab (DRUG).
Who is sponsoring clinical trial NCT04218240?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04218240 being conducted?
This trial has 3 study locations across Maryland, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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