Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Opioid Withdrawal, sponsored by University of Pennsylvania.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
mild = 1-10 moderate=11-20 severe=21-30 higher number equals worse score
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 |
What the finished NCT04218240 record still lists
NCT04218240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 115-participant average among 9 other Opioid Withdrawal trials with a reported enrollment target (22% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Opioid Withdrawal
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04218240's enrollment target sits among peer trials
90 6th of 9 higher than 4 of 9 other Opioid Withdrawal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Withdrawal trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
RECRUITING · Phase 2
-
Evaluating Buspirone to Treat Opioid Withdrawal
ACTIVE NOT RECRUITING · Phase 2
-
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
RECRUITING · Phase 1
-
Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
RECRUITING · NA
-
Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
RECRUITING
-
Sublingual Dexmedetomidine for Treating Opioid Withdrawal
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI