← Back to Search

Opioid Antagonist

Auricular Neurostimulation for Opioid Use Disorder (RESTORE Trial)

N/A

Recruiting

Research Sponsored by Spark Biomedical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is between 18 and 65 years of age

Be older than 18 years old

Must not have

Participant has abnormal ear anatomy or ear infection present

Participant is unwilling to transition to opioid antagonist medication following acute detox treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 7, and monthly throughout phase ii (day 28, 56, and 90)

Summary

This trial is testing whether tAN can help prevent relapse better than extended-release injectable naltrexone.

Who is the study for?

This trial is for adults aged 18-65 with current opioid dependence, experiencing mild to moderate withdrawal. They must be English-speaking, able to consent and participate fully in the study. Excluded are those not switching to opioid antagonist medication post-detox, with neurological issues or ear problems, on long-term opioids like methadone, pregnant or breastfeeding women without proper contraception, and anyone at risk due to other health conditions.

What is being tested?

The trial tests if transcutaneous auricular neurostimulation (tAN) can better prevent relapse in opioid addiction when added to extended-release injectable naltrexone treatment. Participants will also receive Sparrow Ascent Therapy System and Lofexidine during Phase II of the study.

What are the potential side effects?

Possible side effects include reactions related to naltrexone such as nausea, headache, dizziness; Lofexidine may cause low blood pressure or slow heart rate; tAN could potentially lead to skin irritation or discomfort at the stimulation site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an ear infection or my ear structure is not typical.

Select...

I am not willing to switch to medication that blocks opioid effects after detox.

Select...

I am not pregnant or breastfeeding.

Select...

I have been using long-acting opioids like methadone or buprenorphine for 5 or more days.

Select...

I have a history of neurological diseases or traumatic brain injury.

Select...

I have a serious health or mental condition that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 7, and monthly throughout phase ii (day 28, 56, and 90)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 7, and monthly throughout phase ii (day 28, 56, and 90)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 7, and monthly throughout phase ii (day 28, 56, and 90) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Substance Abuse Detection

Self-Report of Drug Use

Secondary study objectives

Opiate Alkaloids

Opioid Craving Scale (OCS)

Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)

Other study objectives

14-Panel Urine Drug Screen in Phase I

Brief Assessment of Recovery Capital (BARC-10) from Phase I to Phase II

Generalized Anxiety Disorder (GAD-7) in Phase I

+9 more

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Active tAN + extended-release injectable naltrexoneExperimental Treatment2 Interventions

Extended-release injectable naltrexone will be administered according to the clinical site's standard of care. Participants will be provided with a Spark Sparrow Ascent Therapy System and instructed to administer therapy according to the specified frequencies: * Month 1 (Days 1 - 28): a minimum of 2 hours per day at least 5 days a week * Month 2 (Days 29 - 56): a minimum of 2 hours per day at least 3 days a week * Month 3 (Days 57 - 90: a minimum of 2 hours per day at least 1 day per week

Group II: Active tAN + lofexidineActive Control2 Interventions

tAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for up to 168 hours (7 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness. Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.

Group III: Sham tAN + placeboActive Control1 Intervention

Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. Participants will receive 3 placebo pills four times per day for 7 days. The placebo will appear similar to lofexidine in size, shape, color, and smell to lofexidine.

Group IV: extended-release injectable naltrexoneActive Control1 Intervention

Extended-release injectable naltrexone will be administered according to the clinical site's standard of care.

Group V: Sham tAN + lofexidinePlacebo Group1 Intervention

Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.

Group VI: Active tAN + placeboPlacebo Group1 Intervention

tAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for up to 168 hours (7 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness. Participants will receive 3 placebo pills four times per day for 7 days. The placebo will appear similar to lofexidine in size, shape, color, and smell to lofexidine.

0 / 7Eligibility criteria met