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NCT05995535 · ClinicalTrials.gov registry record · Phase 2
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
A Phase 2 study of Opioid Use and Opiate Withdrawal Syndrome, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT05995535: Recruiting Phase 2 study of Opioid Use and Opiate Withdrawal Syndrome, sponsored by University of Pennsylvania.
NCT05995535 is a Phase 2 study of Opioid Use and Opiate Withdrawal Syndrome that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 150 participants, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05995535, a Phase 2 study of Opioid Use and Opiate Withdrawal Syndrome, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Subjective patient reported Opioid Withdrawal measured by the SOWS, (0-30); 0 = no withdrawal/30 = severe withdrawal
Conditions Studied
Interventions
- DRUG LFX/PGB
- DRUG LFX/PLA-PGB
Study Locations (2)
Maryland
- Mountain Manor Treatment Center - Baltimore
Pennsylvania
- University of Pennsylvania, Treatment Research Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
What NCT05995535 shows while recruiting
NCT05995535 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Opioid Use appearing as the primary indexed condition, and to 2 interventions - of which LFX/PGB is the first listed.
NCT05995535 reports a single indexed study location in Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05995535 about?
NCT05995535 is a clinical study titled "Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal". 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 compl...
What is the current status of trial NCT05995535?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-01-01. Estimated completion is 2026-08-31.
What conditions does trial NCT05995535 study?
This clinical trial studies the following conditions: Opioid Use, Opiate Withdrawal Syndrome.
What interventions are being tested in trial NCT05995535?
The interventions under investigation include: LFX/PGB (DRUG), LFX/PLA-PGB (DRUG).
Who is sponsoring clinical trial NCT05995535?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05995535 being conducted?
This trial has 2 study locations across Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use
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 NCT05995535's enrollment target sits among peer trials
150 47th of 105 higher than 55 of 105 other Opioid Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use 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.
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