CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
Lofexidine +1 moredrug
Likely dose
Not stated in 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/NCT03718065
NCT03718065Phase 2Completed

Impact of Lofexidine on Stress, Craving and Opioid Use

Medical University of South Carolina·interventional·Posted Oct 24, 2018·Updated Feb 7, 2025

In Brief

A Phase 2 clinical trial evaluating Lofexidine and Placebo for Opioid-use Disorder and Opiate Dependence. Completed, enrolled 112 participants across 1 site.

Detailed Summary

Individuals with opioid use disorder who are stabilized on buprenorphine or methadone will be randomly assigned to receive placebo or lofexidine for 5 weeks. At the end of five weeks, they will complete a human laboratory stress task and scripted opioid imagery task. Throughout the study a CREMA app (Cue Reactivity Ecological Momentary Assessment) will be used to monitor stress, craving and use in the natural environment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 24, 2018
Enrollment StartJun 26, 2019
Primary CompletionJan 30, 2024
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 7.7 years ago

Interventions

Lofexidinedrug

Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.

Placebodrug

Placebo comparator.