EA for Protracted Withdrawal of OUD

NCT04961294 | Unknown

• 1 other identifier: 2018SZ071
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (1)

• Opiate Withdrawal Syndrome Scale

  It consists of three subscales, namely, "anxiety and mood", "fatigue", and "craving". Items are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe PAAS.

  Change from baseline Opiate Withdrawal Syndrome Scale scores at 1 month.

Secondary Outcomes (10)

• Hamilton Depression Scale (HAMD)

  Change from baseline Hamilton Depression Scale scores at 1 month.

• Hamilton Anxiety Scale (HAMA)

  Change from baseline Hamilton Anxiety Scale scores at 1 month.

• Pittsburgh sleep quality index (PSQI)

  Change from baseline Pittsburgh sleep quality index scores at 1 month.

• Concise health survey questionnaire

  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.

• Dopamine (DA)

  baseline and one month

Study Arms (2)

Electro-Acupuncture group

EXPERIMENTAL

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.

Device: Electro-Acupuncture

Wait-list group

NO INTERVENTION

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.

Interventions

Electro-Acupuncture DEVICE

Acupuncture used for thousands years is part of traditional Chinese medicine. We use electro-acupuncture to treat our patients because it is more sufficient than traditional acupuncture and proved effectively treating protracted withdrawal syndrome of opioid use disorder. Paired alligator clips of the EA apparatus will be attached to the needle holders of Shenmen and Neiguan points on both sides. EA stimulation will last for 30 min with a continuous wave of 2/100Hz and intensity of 10-15 mA which patients can stand. All needles will be removed in 30 min and use a dry sterilised cotton ball to press the points in case of bleeding.

Electro-Acupuncture group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Affliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610072, China

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Yulan Ren, PhD

  Chengdu University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Yulan Ren, PhD

CONTACT

0086 13689098226; renxg2468@163.com

YiWei Zeng, M.D

CONTACT

0086 18011566243; YiWei_Zeng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: July 14, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2023
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

CN (1)