Clinical trial NCT04961294: EA for Protracted Withdrawal of OUD
Official title: Electrical Acupuncture for Protracted Withdrawal of Opioid Use Disorder: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid-Related Disorders
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Opiate Withdrawal Syndrome Scale
timeFrame: Change from baseline Opiate Withdrawal Syndrome Scale scores at 1 month.
Secondary outcomes:
measure: Hamilton Depression Scale (HAMD)
timeFrame: Change from baseline Hamilton Depression Scale scores at 1 month.
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: Change from baseline Hamilton Anxiety Scale scores at 1 month.
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: Change from baseline Pittsburgh sleep quality index scores at 1 month.
measure: Concise health survey questionnaire
timeFrame: Change from baseline Concise health survey questionnaire scores at 1 month.All scores were recoded with 0 as a minimum score and 100 as a maximum score; a higher score indicates a better quality of life.
measure: Dopamine (DA)
timeFrame: baseline and one month
measure: 5-hydroxytryptamine (5-HT)
timeFrame: Change from baseline 5-hydroxytryptamine at 1 month.
measure: Liver function
timeFrame: Change from baseline alanine aminotransferase, aspartate aminotransferase, bilirubin total and direct bilirubin at 1 month.
measure: Renal function
timeFrame: Change from baseline serum creatinine, blood uric acid and blood urea nitrogen at 1 month.
measure: Testosterone
timeFrame: Change from baseline Testosterone at 1 month.
measure: Prolactin (PRL)
timeFrame: Change from baseline Prolactin at 1 month.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Affliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Yulan Ren, PhD
role: STUDY_CHAIR
References: