Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- 14-Panel Urine Drug Screen
研究概览
简要总结
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.
详细描述
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):
- Group 1: Active tAN + placebo
- Group 2: Active tAN + lofexidine
- Group 3: Sham tAN + placebo
- 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:
- Group 1: Extended-release injectable naltrexone
- Group 2: Active tAN + extended-release injectable naltrexone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Sparrow Ascent Therapy System (Device)
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.
干预措施: Sparrow Ascent Therapy System (Device)
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.
干预措施: Lofexidine (Drug)
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.
干预措施: Lofexidine (Drug)
extended-release injectable naltrexone
Extended-release injectable naltrexone will be administered according to the clinical site's standard of care.
干预措施: Extended-release injectable naltrexone (Drug)
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
干预措施: Sparrow Ascent Therapy System (Device)
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
干预措施: Extended-release injectable naltrexone (Drug)
结局指标
主要结局
14-Panel Urine Drug Screen
时间窗: 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
时间窗: 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).
次要结局
- 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))