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EA for Protracted Withdrawal of OUD

Primary Purpose

Opioid-Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electro-Acupuncture
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Affliated Hospital of Chengdu University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Electro-Acupuncture group

Wait-list group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hamilton Depression Scale (HAMD)
Assessment for depression.And the interpretation of HAMD scores is as follows: <7, no depression; 7-17, mild depression; 17-24, moderate depression; and >24, severe depression.
Hamilton Anxiety Scale (HAMA)
Assessment for anxiety. And the interpretation of HAMA scores is as follows: <7, no anxiety;7-14, mild anxiety; 14-20, moderate anxiety; 21-28, severe anxiety; and >29, extremely severe anxiety.
Pittsburgh sleep quality index (PSQI)
The scores are from 0 to 21.Higher scores reflect worse sleep quality.
Concise health survey questionnaire
This questionnaire contains 9 parts: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health and Reported Health Transition.
Dopamine (DA)
The physiological parameter to observe the efficiency of acupuncture.
5-hydroxytryptamine (5-HT)
The physiological parameter to observe the efficiency of acupuncture.
Liver function
The physiological parameter to prove the safety of acupuncture.
Renal function
The physiological parameter to prove the safety of acupuncture.
Testosterone
The physiological parameter to observe the efficiency of acupuncture.
Prolactin (PRL)
The physiological parameter to observe the efficiency of acupuncture.

Full Information

First Posted
May 26, 2021
Last Updated
July 10, 2021
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04961294
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electro-Acupuncture group
Arm Type
Experimental
Arm 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.
Arm Title
Wait-list group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Electro-Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opiate Withdrawal Syndrome Scale
Description
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.
Time Frame
Change from baseline Opiate Withdrawal Syndrome Scale scores at 1 month.
Secondary Outcome Measure Information:
Title
Hamilton Depression Scale (HAMD)
Description
Assessment for depression.And the interpretation of HAMD scores is as follows: <7, no depression; 7-17, mild depression; 17-24, moderate depression; and >24, severe depression.
Time Frame
Change from baseline Hamilton Depression Scale scores at 1 month.
Title
Hamilton Anxiety Scale (HAMA)
Description
Assessment for anxiety. And the interpretation of HAMA scores is as follows: <7, no anxiety;7-14, mild anxiety; 14-20, moderate anxiety; 21-28, severe anxiety; and >29, extremely severe anxiety.
Time Frame
Change from baseline Hamilton Anxiety Scale scores at 1 month.
Title
Pittsburgh sleep quality index (PSQI)
Description
The scores are from 0 to 21.Higher scores reflect worse sleep quality.
Time Frame
Change from baseline Pittsburgh sleep quality index scores at 1 month.
Title
Concise health survey questionnaire
Description
This questionnaire contains 9 parts: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health and Reported Health Transition.
Time Frame
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.
Title
Dopamine (DA)
Description
The physiological parameter to observe the efficiency of acupuncture.
Time Frame
baseline and one month
Title
5-hydroxytryptamine (5-HT)
Description
The physiological parameter to observe the efficiency of acupuncture.
Time Frame
Change from baseline 5-hydroxytryptamine at 1 month.
Title
Liver function
Description
The physiological parameter to prove the safety of acupuncture.
Time Frame
Change from baseline alanine aminotransferase, aspartate aminotransferase, bilirubin total and direct bilirubin at 1 month.
Title
Renal function
Description
The physiological parameter to prove the safety of acupuncture.
Time Frame
Change from baseline serum creatinine, blood uric acid and blood urea nitrogen at 1 month.
Title
Testosterone
Description
The physiological parameter to observe the efficiency of acupuncture.
Time Frame
Change from baseline Testosterone at 1 month.
Title
Prolactin (PRL)
Description
The physiological parameter to observe the efficiency of acupuncture.
Time Frame
Change from baseline Prolactin at 1 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yulan Ren, PhD
Phone
0086 13689098226
Email
renxg2468@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
YiWei Zeng, M.D
Phone
0086 18011566243
Email
YiWei_Zeng@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yulan Ren, PhD
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Affliated Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binbin Wu, Doctor
Phone
0086-18190061169
Email
9025340@qq.com

12. IPD Sharing Statement

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EA for Protracted Withdrawal of OUD

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