EA for Protracted Withdrawal of OUD

Chengdu University of Traditional Chinese Medicine

Status: Unknown

Conditions: Opioid-Related Disorders

Treatments: Device: Electro-Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04961294

2018SZ071

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• meet the diagnostic criteria
• the results of detection of morphine in urine is negative
• the patients must be conscious, with no aphasia, no intellectual disability, and graduate from primary school so they can understand what the scale mean and cooperate the treatment.
• not involved in any clinical trials in 3 months
• sign the Informed Consent Form

Exclusion criteria

• with any injury or infection around the acupoint
• the patients are intolerant or allergic to acupuncture or electro-acupuncture
• the women is pregnant or lactating
• patients whose heart, liver or kidney with severe impairment
• according to the judgement from investigators, patients don't correspond with this research

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Electro-Acupuncture group

Experimental group

Description:

The patients in this group will be treated with electro-acupuncture for 30 minutes twice a week in a month. We conduct Nei Guan (PC6), Shen Men (HT7), ZuSanli (ST36), SanYinjiao (SP6) as the major points. Each time treating, according to other symptoms, we will give no more than 2 additional points.

Treatment:

Device: Electro-Acupuncture

Wait-list group

No Intervention group

Description:

We give no intervention to the patients this group during the whole experiment. When finishing, the same ways of treatment will be given to these patients.