EA for PAAS: A pRCT
Electro-acupuncture for Protracted Amphetamine Abstinence Syndrome : A Pragmatic Randomized Controlled Trial
1 other identifier
interventional
1,000
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 8, 2021
June 1, 2021
1.1 years
May 26, 2021
June 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Change from baseline Amphetamine Cessation Symptom Assessment scores at 1 month.
Secondary Outcomes (5)
Visual Analog Scale
Change from baseline Visual Analog Scale scores at 1 month.
Hamilton Depression Scale
Change from baseline Hamilton Depression Scale scores at 1 month.
Hamilton Anxiety Scale
Change from baseline Hamilton Anxiety Scale scores at 1 month.
Pittsburgh Sleep Quality Index
Change from baseline Pittsburgh Sleep Quality Index scores at 1 month.
36-item Short Form Health Survey
Change from baseline 36-item Short Form Health Survey scores at 1 month.
Study Arms (2)
Electro-Acupuncture group
EXPERIMENTALThe 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 INTERVENTIONWe 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
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yulan Ren, PhD
Chengdu University of Traditional Chinese Medicine
Central Study Contacts
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
June 8, 2021
Study Start
June 1, 2021
Primary Completion
July 1, 2022
Study Completion
December 1, 2023
Last Updated
June 8, 2021
Record last verified: 2021-06