EA for PAAS: A pRCT

• ClinicalTrials.gov Identifier: NCT04917185
• Recruitment Status: Recruiting
• First Posted: June 8, 2021
• Last Update Posted: June 8, 2021
• Sponsor: Chengdu University of Traditional Chinese Medicine
• Information provided by (Responsible Party): Ren Yu-Lan, Chengdu University of Traditional Chinese Medicine

Tracking Information

• First Submitted Date: May 26, 2021
• First Posted Date: June 8, 2021
• Last Update Posted Date: June 8, 2021
• Estimated Study Start Date: June 2021
• Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 7, 2021)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 7, 2021)

• Visual Analog Scale [ Time Frame: Change from baseline Visual Analog Scale scores at 1 month. ]
  Determining the craving for amphetamine.The scores is from 0 to 10, and the higher scores means the more craving for amphetamine.
• Hamilton Depression Scale [ Time Frame: Change from baseline Hamilton Depression Scale scores at 1 month. ]
  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.
• Hamilton Anxiety Scale [ Time Frame: Change from baseline Hamilton Anxiety Scale scores at 1 month. ]
  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.
• Pittsburgh Sleep Quality Index [ Time Frame: Change from baseline Pittsburgh Sleep Quality Index scores at 1 month. ]
  The scores are from 0 to 21.Higher scores reflect worse sleep quality.
• 36-item Short Form Health Survey [ Time Frame: Change from baseline 36-item Short Form Health Survey scores at 1 month. ]
  This questionnaire contains 9 parts: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health and Reported Health Transition.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EA for PAAS: A pRCT
• Official Title: Electro-acupuncture for Protracted Amphetamine Abstinence Syndrome : A Pragmatic Randomized Controlled Trial

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Substance Withdrawal Syndrome

Intervention

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.

Study Arms

• Experimental: Electro-Acupuncture group
  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.
  Intervention: Other: Electro-Acupuncture
• No Intervention: Wait-list group
  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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 7, 2021): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Yulan Ren, PhD; 0086 13689098226; renxg2468@163.com

Contact: Yiwei Zeng, M.D; 0086 18011566243; YiWei_Zeng@163.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04917185
• Other Study ID Numbers: 18ZDYF3417
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ren Yu-Lan, Chengdu University of Traditional Chinese Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Chengdu University of Traditional Chinese Medicine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Yulan Ren, PhD; Chengdu University of Traditional Chinese Medicine

• PRS Account: Chengdu University of Traditional Chinese Medicine
• Verification Date: June 2021