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Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder — RESTORE  

Opioid-use Disorder Clinical Trial

Official title:
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder

Clinical Trial Summary

The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.

Clinical Trial Description

This is a prospective, randomized, controlled, multi-center, clinical trial in which participants with a history of dependence on prescriptive or non-prescriptive opioids will be randomized 2:1 into one of four treatment groups during Phase I (acute detoxification, 7 days): 1. Group 1: Active tAN + placebo 2. Group 2: Active tAN + lofexidine 3. Group 3: Sham tAN + placebo 4. Group 4: Sham tAN + lofexidine Phase I will occur during the participant's treatment in a residential detox center. Participants will have the option to continue into Phase II of the trial at the conclusion of their stay in the residential detox treatment program. In Phase II, participants will be re-randomized 1:1 into one of two treatment groups and will return weekly for 90 days: 1. Group 1: Extended-release injectable naltrexone 2. Group 2: Active tAN + extended-release injectable naltrexone ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05053503
Study type Interventional
Source Spark Biomedical, Inc.
Contact Puja Patel
Phone 919-986-1619
Email ppatel@mcra.com
Status Recruiting
Phase N/A
Start date May 25, 2022
Completion date October 2024
View Details
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