EA for PAAS: A pRCT

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.

Conditions

• Substance Withdrawal Syndrome

Interventions

OTHER

Electro-Acupuncture

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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Yulan Ren, PhD · Chengdu University of Traditional Chinese Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-30

Primary Completion

2022-07-31

Completion

2023-12-31

Countries

• China

Study Locations