Substance Withdrawal SyndromeNCT04917185
EA for PAAS: A pRCT
A study testing Electro-Acupuncture in people with Substance Withdrawal Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
In 2019, around 27 million people worldwide, corresponding to 0.5% of the adult population, have used amphetamine-type stimulants (ATS). More than one-third of these 27 million users of ATS were in East and South-East Asia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Withdrawal Syndrome
- What is being tested?
- Electro-Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 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
- Patients meet the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (21);
- A urine test for methamphetamine is negative.
- 18-60 years old, male or female, conscious, no aphasia, or mental retardation, primary school education or above, and able to understand the contents of the scales and cooperate with treatment;
- Did not participate in other clinical trials within 3 months;
- Signed the informed consent from.
Who cannot join
- Local trauma or infected persons who have received EA;
- Can' not tolerate EA, EA treatment, or allergic to EA needles;
- Pregnant or breastfeeding women;
- Serious disorders of the heart, liver, or kidney, or suicidal tendencies.
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: Electro-acupuncture for Protracted Amphetamine Abstinence Syndrome : A Pragmatic Randomized Controlled Trial
In 2019, around 27 million people worldwide, corresponding to 0.5% of the adult population, have used amphetamine-type stimulants (ATS). More than one-third of these 27 million users of ATS were in East and South-East Asia. ATS are a group of synthetic psychostimulants including methamphetamine, amphetamine, 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) and related substances. Although the biology underlying amphetamine withdrawal syndrome is not fully understood, amphetamine has been shown to produce long-lasting reductions in neuronal expression of dopamine neuronal markers. Abuse of these synthetic psychostimulants can lead to drug addiction, and subsequent withdrawal can cause a series of mental symptoms, such as anxiety, depression, confusion, insomnia, mood disturbances, cognitive impairments, and delusions. Some studies have shown two clear stages of ATS withdrawal syndrome: an acute phase lasting 7-10 days, and a subacute phase lasting a further 2 weeks or more, which is termed called "Protracted amphetamine abstinence syndrome (PAAS)".
The relevant literature has indicated that the majority of patients with ATS withdrawal disorders can experience depression, cognitive impairments, insomnia, and anxiety, especially during the PAAS stage. These symptoms may affect the treatment and finally lead to a relapse. Nowadays, pharmacological therapies are mostly symptom-targeted and show an ungratified effectiveness for amphetamine-type drugs. There is no a medication approved by Food and Drug Administration for use in the treatment of methamphetamine addiction. Therefore, the treatment of PAAS is essential for the treatment of ATS use disorders.
Read more
Traditional Chinese medicine (TCM), especially acupuncture, is effective in the treatment of withdrawal symptoms with few side effects. research on acupuncture detoxification originates from the treatment of opioid drug withdrawal. Studies have shown that acupuncture has high efficacy in the treatment of protracted abstinence symptoms after heroin addiction. This study hypothesizes that acupuncture has the same mechanism of action in the treatment of PAAS as in the treatment of protracted opioid abstinence syndrome. Therefore, investigators have designed a real-world-based pragmatic randomized controlled trial (pRCT) to determine the effectiveness of acupuncture in the treatment of PAAS and provide support for clinical decision-making.
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
- Substance Withdrawal Syndrome
- Being tested
- Electro-Acupuncture
- Medical subject headings
- Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-AcupunctureOther
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: Other: 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.
Amphetamine Cessation Symptom Assessment
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 Amphetamine Cessation Symptom
Measured: Change from baseline Amphetamine Cessation Symptom Assessment scores at 1 month.
Secondary outcomes (5)
Visual Analog Scale
Determining the craving for amphetamine.The scores is from 0 to 10, and the higher scores means the more craving for amphetamine.
Measured: Change from baseline Visual Analog Scale scores at 1 month.
Hamilton Depression Scale
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
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
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.
36-item Short Form Health Survey
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 36-item Short Form Health Survey scores 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 posted8 Jun 2021
- Study startJun 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 Substance Withdrawal SyndromeStudies 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
- 1,000 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
- NCT04917185
- Sponsor's protocol ID
- 18ZDYF3417
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 8 Jun 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 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-acupuncture for Protracted Amphetamine Abstinence Syndrome : A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04917185
- Acronym / sponsor ID
- 18ZDYF3417
- Conditions
- Substance Withdrawal Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Jun 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.
In 2019, around 27 million people worldwide, corresponding to 0.5% of the adult population, have used amphetamine-type stimulants (ATS). More than one-third of these 27 million users of ATS were in East and South-East Asia. ATS are a group of synthetic psychostimulants including methamphetamine, amphetamine, 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) and related substances. Although the biology underlying amphetamine withdrawal syndrome is not fully understood, amphetamine has been shown to produce long-lasting reductions in neuronal expression of dopamine neuronal markers. Abuse of these synthetic psychostimulants can lead to drug addiction, and subsequent withdrawal can cause a series of mental symptoms, such as anxiety, depression, confusion, insomnia, mood disturbances, cognitive impairments, and delusions. Some studies have shown two clear stages of ATS withdrawal syndrome: an acute phase lasting 7-10 days, and a subacute phase lasting a further 2 weeks or more, which is termed called "Protracted amphetamine abstinence syndrome (PAAS)".
The relevant literature has indicated that the majority of patients with ATS withdrawal disorders can experience depression, cognitive impairments, insomnia, and anxiety, especially during the PAAS stage. These symptoms may affect the treatment and finally lead to a relapse. Nowadays, pharmacological therapies are mostly symptom-targeted and show an ungratified effectiveness for amphetamine-type drugs. There is no a medication approved by Food and Drug Administration for use in the treatment of methamphetamine addiction. Therefore, the treatment of PAAS is essential for the treatment of ATS use disorders.
Traditional Chinese medicine (TCM), especially acupuncture, is effective in the treatment of withdrawal symptoms with few side effects. research on acupuncture detoxification originates from the treatment of opioid drug withdrawal. Studies have shown that acupuncture has high efficacy in the treatment of protracted abstinence symptoms after heroin addiction. This study hypothesizes that acupuncture has the same mechanism of action in the treatment of PAAS as in the treatment of protracted opioid abstinence syndrome. Therefore, investigators have designed a real-world-based pragmatic randomized controlled trial (pRCT) to determine the effectiveness of acupuncture in the treatment of PAAS and provide support for clinical decision-making.
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 | Other: 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)
- Patients meet the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (21);
- A urine test for methamphetamine is negative.
- 18-60 years old, male or female, conscious, no aphasia, or mental retardation, primary school education or above, and able to understand the contents of the scales and cooperate with treatment;
- Did not participate in other clinical trials within 3 months;
- Signed the informed consent from.
Key exclusion criteria (4 listed)
- Local trauma or infected persons who have received EA;
- Can' not tolerate EA, EA treatment, or allergic to EA needles;
- Pregnant or breastfeeding women;
- Serious disorders of the heart, liver, or kidney, or suicidal tendencies.
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. | Other | Electro-Acupuncture group |
Primary outcome
Amphetamine Cessation Symptom Assessment
Time frame: Change from baseline Amphetamine Cessation Symptom Assessment 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 Amphetamine Cessation Symptom
5 secondary outcomes
Visual Analog Scale
Time frame: Change from baseline Visual Analog Scale scores at 1 month.
Hamilton Depression Scale
Time frame: Change from baseline Hamilton Depression Scale scores at 1 month.
Hamilton Anxiety Scale
Time frame: Change from baseline Hamilton Anxiety Scale scores at 1 month.
Pittsburgh Sleep Quality Index
Time frame: Change from baseline Pittsburgh Sleep Quality Index scores at 1 month.
36-item Short Form Health Survey
Time frame: Change from baseline 36-item Short Form Health Survey scores 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 8 Jun 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 Substance Withdrawal Syndrome, 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 4 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 8 Jun 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?
Amphetamine Cessation Symptom Assessment (time frame: Change from baseline Amphetamine Cessation Symptom Assessment 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 8 Jun 2021.