CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Pregabalin 200 MG capsules +2 moredrug
Likely dose
Pregabalin 200 MG capsulesfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04218240
NCT04218240Phase 2Completed
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Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?

University of Pennsylvania·interventional·Posted Jan 6, 2020·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Pregabalin 200 MG capsules, Placebo oral tablet, and 1 other intervention for Opioid Withdrawal. Completed, enrolled 90 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Withdrawal
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 6, 2020
Enrollment StartDec 17, 2020
Primary CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.5 years ago

Interventions

Pregabalin 200 MG capsulesdrug

oral pregabalin 200 mg capsules given with a taper on day 5

Placebo oral tabletdrug

oral Placebo

Lofexidine 0.18Mg Tabdrug

lofexidine 0.18 tab given with a taper starting on day 5