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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 7, and monthly throughout phase ii (day 28, 56, and 90)
Awards & highlights

RESTORE Trial 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.Check my eligibility
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.See study design
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.

RESTORE Trial 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.

RESTORE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Substance Abuse Detection
Self-Report of Drug Use
Secondary outcome measures
Opiate Alkaloids
Opioid Craving Scale (OCS)
Proportion of patients who receive and tolerate an XR-NTX injection after acute detox treatment (Phase I)
+1 more
Other outcome measures
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

RESTORE 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: 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.
Group VI: 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.

Find a Location

Who is running the clinical trial?

Hazelden Betty Ford FoundationUNKNOWN
1 Previous Clinical Trials
150 Total Patients Enrolled
Spark Biomedical, Inc.Lead Sponsor
6 Previous Clinical Trials
299 Total Patients Enrolled
Gaudenzia, Inc.UNKNOWN

Media Library

Extended-release injectable naltrexone (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05053503 — N/A
Opioid Use Disorder Research Study Groups: Active tAN + lofexidine, Active tAN + placebo, Sham tAN + placebo, Sham tAN + lofexidine, extended-release injectable naltrexone, Active tAN + extended-release injectable naltrexone
Opioid Use Disorder Clinical Trial 2023: Extended-release injectable naltrexone Highlights & Side Effects. Trial Name: NCT05053503 — N/A
Extended-release injectable naltrexone (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05053503 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range of participants in this experiment inclusive of those over 75?

"This study is looking for volunteers aged 18 and above, but not exceeding 65."

Answered by AI

What therapeutic benefits does Naltrexone Injection provide?

"Naltrexone Injection is often prescribed for the long-term management of weight, but can also be employed to stimulate physical activity and regulate pain associated with calorie restriction."

Answered by AI

How many participants are involved in this clinical trial?

"Affirmative, clinicaltrials.gov documents indicate that this scientific investigation is actively enrolling participants. The trial was originally posted on May 25th 2022 and saw its most recent update in October 19th 2022; it requires 168 volunteers from 3 distinct sites."

Answered by AI

Who is the ideal candidate to join this experimental investigation?

"This medical trial is enrolling 168 participants, aged 18 to 65, that have been diagnosed with opioid use disorder (OUD). To qualify for this study, patients must present a COWS score of 8 or higher and be deemed in mild-to-moderate withdrawal at baseline assessment. Additionally, they should display signs of current dependence on opioids - whether through prescription or illicit means."

Answered by AI

Has Naltrexone Injection been studied in prior research endeavors?

"Naltrexone Injection was first examined in 2007 at Columbia Addiction Services and Psychotherapy Intervention Research. 258 trials have concluded, with 49 still active studies mainly based out of Baltimore, Maryland."

Answered by AI

Are there still vacancies on this clinical experiment for participants?

"According to records on clinicaltrials.gov, this medical trial is currently enrolling participants; the study was advertised publicly for the first time on May 25th 2022 and underwent its most recent update in October of that same year."

Answered by AI
~36 spots leftby Oct 2024