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Pregabalin and Lofexidine for Opioid Withdrawal
NCT04218240Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2020
- Primary completion
- Aug 2023
- Countries
- 1
- Sponsor
- University of Pennsylvania
- Modality
- Small Molecules
- Drugs
- pregabalin
- Conditions
- opioid withdrawal
01
Overview
Phase 2, randomised, double-blind trial of pregabalin in opioid withdrawal (2 arms), sponsored by University of Pennsylvania. Primary endpoint: Subjective Opioid Withdrawal Scale-Gossop at 7 days. Started Dec 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PGB/LFX
Pregabalin + Lofexidine
Lofexidine + Placebo
Placebo + Lofexidine
03
Who it enrols
Adults with Opioid Use Disorder interested in antagonist treatment, without serious medical/psychiatric conditions or specific drug interactions.
04
Endpoints
Primary
Subjective Opioid Withdrawal Scale-Gossop
Secondary
Completion of Withdrawal Management
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