Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT04961294
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2021-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EA for Protracted Withdrawal of OUD
Sponsor:
Chengdu University of Traditional Chinese Medicine
Organization:
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 diseases.The "World Drug Report 2020" has declared that 58 million people used opioids in 2018 and some 35.6 million people suffered from drug use disorders globally. More than 11 million people inject drugs, while 1.4 million PWID are living with HIV, 5.5 million with hepatitis C and 1.2 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 trials(pRCT) 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.
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 trials(pRCT) 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?: