Viewing Study NCT04961294



Ignite Creation Date: 2024-05-06 @ 4:22 PM
Last Modification Date: 2024-10-26 @ 2:08 PM
Study NCT ID: NCT04961294
Status: UNKNOWN
Last Update Posted: 2021-07-14
First Post: 2021-05-26

Brief Title: EA for Protracted Withdrawal of OUD
Sponsor: Chengdu University of Traditional Chinese Medicine
Organization: Chengdu University of Traditional Chinese Medicine

Study Overview

Official Title: Electrical Acupuncture for Protracted Withdrawal of Opioid Use Disorder A Pragmatic Randomized Controlled Trial
Status: UNKNOWN
Status Verified Date: 2021-07
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Opioid use disorder OUD the most harmful of all the illicit drugs is a serious substance-related disorder resulting from abuse or misuse of opioids Huge number of patients are addictive to opioid and evidences show that patients with OUD have high rates of infectious diseasesThe World Drug Report 2020 has declared that 58 million people used opioids in 2018 and some 356 million people suffered from drug use disorders globally More than 11 million people inject drugs while 14 million PWID are living with HIV 55 million with hepatitis C and 12 million are living with both hepatitis C and HIV

The long-term physical and mental symptoms of some opioid drug users after detoxification treatment are called protracted opioid withdrawal syndrome POAS POAS is one of the important causes of relapse Methadone maintenance treatment is the most widespread and extensively researched treatment for heroin addiction and has been shown to reduce the frequency of opioid use the mortality and the transmission of human immunodeficiency virus and viral hepatitis But higher daily methadone dose and increasing duration of treatment conduce the addiction in methadone Other medication therapy like naltrexone treatment is also associated with high rates of noncompliance and opioid relapse Meanwhile relapse to heroin use following cessation of agonist maintenance treatment is common The problems associated with use of opioid agonists have made it necessary to develop non-opioid therapies to ameliorate the symptoms of acute and protracted opioid withdrawal

Acupuncture based on traditional Chinese medicine TCM theory is becoming a popular complementary and alternative treatment worldwide Study showed that acupuncture reduced the depression symptoms and cravings of patients under methadone maintenance treatment Another study by Le et al 2016 showed that electric acupuncture has been associated with a reduction in depressive symptoms through the adjustment of HPA axis function and increasing the hippocampus activity And also some research show the efficiency of acupuncture in treating mice with OUD

Investigators conduct a pragmatic randomized controlled trialspRCT to observe the effect of acupuncture in a larger sample It combines the advantages of randomization and real-world data and the results can provide the best real-world evidence for the assessment of intervention effects or comparative effects
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None