Clinical trial NCT04917185: EA for PAAS: A pRCT
Official title: Electro-acupuncture for Protracted Amphetamine Abstinence Syndrome : A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Withdrawal Syndrome
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Amphetamine Cessation Symptom Assessment
timeFrame: Change from baseline Amphetamine Cessation Symptom Assessment scores at 1 month.
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Change from baseline Visual Analog Scale scores at 1 month.
measure: Hamilton Depression Scale
timeFrame: Change from baseline Hamilton Depression Scale scores at 1 month.
measure: Hamilton Anxiety Scale
timeFrame: Change from baseline Hamilton Anxiety Scale scores at 1 month.
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from baseline Pittsburgh Sleep Quality Index scores at 1 month.
measure: 36-item Short Form Health Survey
timeFrame: Change from baseline 36-item Short Form Health Survey scores at 1 month.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Affliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Yulan Ren, PhD
role: STUDY_CHAIR
References: