NCT05053503

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Spark Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Opioid-use Disorder
• Opioid Withdrawal

Interventions

Type	Name	Description
DEVICE	Sparrow Ascent Therapy System	Transcutaneous auricular neurostimulation (tAN)
DRUG	Lofexidine	Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.
DRUG	Extended-release injectable naltrexone	Participants will receive extended-release injectable naltrexone based on the clinical site's standard of care.

Timeline

• Start date: 2022-05-27
• Primary completion: 2025-04-04
• Completion: 2025-04-04
• First posted: 2021-09-22
• Last updated: 2025-07-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study