Clinical trial NCT05053503: Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
Official title: Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Opioid Withdrawal
Keywords: auricular neurostimulation
vagus nerve stimulation
transcutaneous
withdrawal symptoms
relapse prevention
Lead sponsor: Spark Biomedical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hazelden Betty Ford Foundation
name: Gaudenzia, Inc.
First posted: 2021-09-22
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model 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). 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 purpose: PREVENTION

Brief 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

Eligibility 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

Primary outcomes:
measure: 14-Panel Urine Drug Screen
timeFrame: Weekly throughout Phase II (13 weeks)
measure: Self-Report of Drug Use
timeFrame: Weekly throughout Phase II (13 weeks)
Secondary outcomes:
measure: Clinical Opiate Withdrawal Scale (COWS)
timeFrame: 60 minutes after treatment initiation (Day 1, Phase I)
measure: Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
timeFrame: 60 minutes after treatment initiation (Day 1, Phase I)
measure: Clinical Opiate Withdrawal Scale (COWS)
timeFrame: 6 hours after treatment initiation (Day 1, Phase I)
measure: Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
timeFrame: 6 hours after treatment initiation (Day 1, Phase I)
measure: Clinical Opiate Withdrawal Scale (COWS)
timeFrame: Daily on Days 2-7 of Phase I
measure: Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
timeFrame: Daily on Days 2-7 of Phase I
measure: Opioid Craving Scale (OCS)
timeFrame: Weekly throughout Phase II (13 weeks)
measure: Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
timeFrame: Weekly throughout Phase II (13 weeks)
measure: Proportion of patients who receive and tolerate an XR-NTX injection after acute detox treatment (Phase I)
timeFrame: One hour after receiving first XR-NTX injection (Phase II Day 1)
Other outcomes:
measure: Patient Health Questionnaire (PHQ-9) in Phase I
timeFrame: Baseline and Day 7
measure: Patient Health Questionnaire (PHQ-9) in Phase II
timeFrame: Monthly throughout Phase II (Day 28, 56, and 90)
measure: PTSD Checklist for DSM-5 (PCL-5) in Phase I
timeFrame: Baseline and Day 7
measure: PTSD Checklist for DSM-5 (PCL-5) in Phase II
timeFrame: Monthly throughout Phase II (Day 28, 56, and 90)
measure: Generalized Anxiety Disorder (GAD-7) in Phase I
timeFrame: Baseline and Day 7
measure: Generalized Anxiety Disorder (GAD-7) in Phase II
timeFrame: Monthly throughout Phase II (Day 28, 56, and 90)
measure: World Health Organization Quality of Life (WHOQOL-BREF) in Phase I
timeFrame: Baseline and Day 7
measure: World Health Organization Quality of Life (WHOQOL-BREF) in Phase II
timeFrame: Monthly throughout Phase II (Day 28, 56, and 90)
measure: Brief Assessment of Recovery Capital (BARC-10) from Phase I to Phase II
timeFrame: Baseline, Day 7, and monthly throughout Phase II (Day 28, 56, and 90)
measure: Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop) in Phase II
timeFrame: Weekly throughout Phase II (13 weeks)
measure: 14-Panel Urine Drug Screen in Phase I
timeFrame: Baseline and Day 7
measure: Xylazine Test Strip Screen in Phase I and Phase II
timeFrame: Baseline, Phase I Day 7, and weekly throughout Phase II (13 weeks)
Locations:
city: Rancho Mirage
country: United States
facility: Hazelden Betty Ford Foundation
state: California
city: Crownsville
country: United States
facility: Gaudenzia, Inc.
state: Maryland
city: Center City
country: United States
facility: Hazelden Betty Ford Foundation
state: Minnesota
city: Plymouth
country: United States
facility: Hazelden Betty Ford Foundation
state: Minnesota
Study officials:
References: