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

Spark Biomedical

Status: Completed

Conditions: Opioid Withdrawal; Opioid-use Disorder

Treatments: Device: Sparrow Ascent Therapy System; Drug: Extended-release injectable naltrexone; Drug: Lofexidine

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05053503

SBM-OWP-03

Details and patient eligibility

About

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.

Full 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

Enrollment: 108 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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108 participants in 6 patient groups, including a placebo group

Active tAN + placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Sparrow Ascent Therapy System

Active tAN + lofexidine

Active Comparator group

Description:

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.

Treatment:

Drug: Lofexidine

Device: Sparrow Ascent Therapy System

Sham tAN + placebo

No Intervention group

Description:

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.

Sham tAN + lofexidine

Sham Comparator group

Description:

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.

Treatment:

Drug: Lofexidine

extended-release injectable naltrexone

Active Comparator group

Description:

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

Treatment:

Drug: Extended-release injectable naltrexone

Active tAN + extended-release injectable naltrexone

Experimental group

Description:

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

Treatment:

Drug: Extended-release injectable naltrexone

Device: Sparrow Ascent Therapy System