Opioid-Related DisordersNCT04961294
EA for Protracted Withdrawal of OUD
A study testing Electro-Acupuncture in people with Opioid-Related Disorders, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Electro-Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jul 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072
Binbin Wu, Doctor, 0086-18190061169, 9025340@qq.com
About this study
Official title: Electrical Acupuncture for Protracted Withdrawal of Opioid Use Disorder: A Pragmatic Randomized Controlled Trial
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.
Read more
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
- Being tested
- Electro-Acupuncture
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline Opiate Withdrawal Syndrome Scale scores at 1 month.
Secondary outcomes (10)
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.
Measured: Change from baseline Hamilton Depression Scale scores at 1 month.
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.
Measured: Change from baseline Hamilton Anxiety Scale scores at 1 month.
Pittsburgh sleep quality index (PSQI)
The scores are from 0 to 21.Higher scores reflect worse sleep quality.
Measured: Change from baseline Pittsburgh sleep quality index scores at 1 month.
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.
Measured: 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)
The physiological parameter to observe the efficiency of acupuncture.
Measured: baseline and one month
5-hydroxytryptamine (5-HT)
The physiological parameter to observe the efficiency of acupuncture.
Measured: Change from baseline 5-hydroxytryptamine at 1 month.
Liver function
The physiological parameter to prove the safety of acupuncture.
Measured: Change from baseline alanine aminotransferase, aspartate aminotransferase, bilirubin total and direct bilirubin at 1 month.
Renal function
The physiological parameter to prove the safety of acupuncture.
Measured: Change from baseline serum creatinine, blood uric acid and blood urea nitrogen at 1 month.
Testosterone
The physiological parameter to observe the efficiency of acupuncture.
Measured: Change from baseline Testosterone at 1 month.
Prolactin (PRL)
The physiological parameter to observe the efficiency of acupuncture.
Measured: Change from baseline Prolactin at 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Yu-Lan, Chengdu University of Traditional Chinese Medicine
- Investigators
- Yulan Ren, PhD, Study chair, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961294
- Sponsor's protocol ID
- 2018SZ071
- Status last verified
- Jul 2021
- First submitted
- 26 May 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Acupuncture for Protracted Withdrawal of Opioid Use Disorder: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04961294
- Acronym / sponsor ID
- 2018SZ071
- Conditions
- Opioid-Related Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electro-Acupuncture group | Experimental | Device: Electro-AcupunctureThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-AcupunctureAcupuncture 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. | Device | Electro-Acupuncture group |
Primary outcome
Opiate Withdrawal Syndrome Scale
Time frame: Change from baseline Opiate Withdrawal Syndrome Scale scores at 1 month.
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.
10 secondary outcomes
Hamilton Depression Scale (HAMD)
Time frame: Change from baseline Hamilton Depression Scale scores at 1 month.
Hamilton Anxiety Scale (HAMA)
Time frame: Change from baseline Hamilton Anxiety Scale scores at 1 month.
Pittsburgh sleep quality index (PSQI)
Time frame: Change from baseline Pittsburgh sleep quality index scores at 1 month.
Concise health survey questionnaire
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.
Dopamine (DA)
Time frame: baseline and one month
5-hydroxytryptamine (5-HT)
Time frame: Change from baseline 5-hydroxytryptamine at 1 month.
Liver function
Time frame: Change from baseline alanine aminotransferase, aspartate aminotransferase, bilirubin total and direct bilirubin at 1 month.
Renal function
Time frame: Change from baseline serum creatinine, blood uric acid and blood urea nitrogen at 1 month.
Testosterone
Time frame: Change from baseline Testosterone at 1 month.
Prolactin (PRL)
Time frame: Change from baseline Prolactin at 1 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yulan Ren, PhD study chair
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-Acupuncture in people with Opioid-Related Disorders, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yulan Ren, PhD (0086 13689098226, renxg2468@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiate Withdrawal Syndrome Scale (time frame: Change from baseline Opiate Withdrawal Syndrome Scale scores at 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.