Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Sparrow Ascent Therapy System
- Conditions
- Opioid-use Disorder
- Sponsor
- Spark Biomedical, Inc.
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- 14-Panel Urine Drug Screen
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Sparrow Ascent Therapy System
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.
Intervention: Sparrow Ascent Therapy System
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.
Intervention: Lofexidine
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.
Intervention: Lofexidine
extended-release injectable naltrexone
Extended-release injectable naltrexone will be administered according to the clinical site's standard of care.
Intervention: Extended-release injectable naltrexone
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
Intervention: Sparrow Ascent Therapy System
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
Intervention: Extended-release injectable naltrexone
Outcomes
Primary Outcomes
14-Panel Urine Drug Screen
Time Frame: Weekly throughout Phase II (13 weeks)
In Phase II, participants will provide a weekly urine sample to determine if opioids have been used in the past week (in conjunction with a self-report). A urine drug screen cup will be used to detect presence of: Amphetamines, Buprenorphine, Benzodiazepines, Cocaine, Ethyl Glucuronide, Fentanyl, Synthetic Marijuana, Ecstasy, Methamphetamines, Methadone, Opiates / Morphine, Oxycodone, Cannabinoid (Marijuana), and Tramadol. The urine drug screen cup also contains a temperature strip to confirm appropriate temperature of the sample and an adulteration panel for determination of sample tampering.
Self-Report of Drug Use
Time Frame: Weekly throughout Phase II (13 weeks)
In Phase II, participants will be asked weekly to self-report any use of opioids to determine if opioids have been used in the past week (in conjunction with a UDS sample).
Secondary Outcomes
- Clinical Opiate Withdrawal Scale (COWS)(Daily on Days 2-7 of Phase I)
- Opioid Craving Scale (OCS)(Weekly throughout Phase II (13 weeks))
- Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)(Weekly throughout Phase II (13 weeks))
- Proportion of patients who receive and tolerate an XR-NTX injection after acute detox treatment (Phase I)(One hour after receiving first XR-NTX injection (Phase II Day 1))