Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04917185
Status:
UNKNOWN
Last Update Posted:
2021-06-08
First Post:
2021-05-26
Brief Title:
EA for PAAS A pRCT
Sponsor:
Chengdu University of Traditional Chinese Medicine
Organization:
Chengdu University of Traditional Chinese Medicine
Study Overview
Official Title:
Electro-acupuncture for Protracted Amphetamine Abstinence Syndrome A Pragmatic Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In 2019 around 27 million people worldwide corresponding to 05 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 34-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 trialspRCT 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
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 trialspRCT 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None