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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2025-04-04

Brief Summary

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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.

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Detailed Description

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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

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Opioid-use Disorder Opioid Withdrawal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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). 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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All study investigators will be blind to patient treatment group assignment. Furthermore, each clinical site will use qualified COWS assessors that will be blind to randomization group assignment. This will ensure a non-biased assessment of opioid withdrawal symptoms. Information regarding study intervention will be withheld from the blinded COWS assessors. All participants will be blinded to their group assignment during acute detox treatment (Phase I). Participants will not be unblinded to their Phase I treatment until study exit, which may occur at the end of Phase II for participants who continue in the study. Participants will not be blinded to their treatment group during Phase II.

Study Groups

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Active tAN + placebo

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 Type PLACEBO_COMPARATOR

Sparrow Ascent Therapy System

Intervention Type DEVICE

Transcutaneous auricular neurostimulation (tAN)

Active tAN + lofexidine

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 Type ACTIVE_COMPARATOR

Sparrow Ascent Therapy System

Intervention Type DEVICE

Transcutaneous auricular neurostimulation (tAN)

Lofexidine

Intervention Type DRUG

Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.

Sham tAN + placebo

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 Type NO_INTERVENTION

No interventions assigned to this group

Sham tAN + lofexidine

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 Type SHAM_COMPARATOR

Lofexidine

Intervention Type DRUG

Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.

extended-release injectable naltrexone

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

Group Type ACTIVE_COMPARATOR

Extended-release injectable naltrexone

Intervention Type DRUG

Participants will receive extended-release injectable naltrexone based on the clinical site's standard of care.

Active tAN + extended-release injectable naltrexone

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 Type EXPERIMENTAL

Sparrow Ascent Therapy System

Intervention Type DEVICE

Transcutaneous auricular neurostimulation (tAN)

Extended-release injectable naltrexone

Intervention Type DRUG

Participants will receive extended-release injectable naltrexone based on the clinical site's standard of care.

Interventions

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Sparrow Ascent Therapy System

Transcutaneous auricular neurostimulation (tAN)

Intervention Type DEVICE

Lofexidine

Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.

Intervention Type DRUG

Extended-release injectable naltrexone

Participants will receive extended-release injectable naltrexone based on the clinical site's standard of care.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Participant shows signs of current opioid dependence; prescription or non-prescription
2. Participant COWS score is ≥ 8 or in the opinion of the investigator the participant is in mild to moderate withdrawal at the baseline assessment
3. Participant is between 18 and 65 years of age
4. Participant is English proficient
5. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria

1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
2. Participant has a history of epileptic seizures
3. Participant has a history of neurological diseases or traumatic brain injury
4. Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
5. Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
6. Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
7. Participant has abnormal ear anatomy or ear infection present
8. Participant is unwilling to transition to opioid antagonist medication following acute detox treatment
9. Subject has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial
10. Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
11. Females who are pregnant or lactating
12. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No