Positive Effects of Laser Acupuncture in Methamphetamine Users Undergoing Group Cognitive Behavioral Therapy: A Pilot Study

Study Overview
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Brief Summary
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Methamphetamine (MA) addiction has become a crucial public health issue due to its adverse effects. Acupuncture has been used for drug detoxification for many years. However, some disadvantages are not be suitable for MA users. The advantages of laser acupuncture includes safety, painless, less time consuming and higher acceptability without current investigation. Therefore, investigators arrange this study to evaluate the efficacy of laser acupuncture combined with golden treatment of cognitive group therapy.

Detailed Description
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Methamphetamine (MA) addiction has become a crucial public health concern because of its adverse consequences to individuals and the society. Manual or auricular acupuncture have been applied in opioid dependence treatment for a long time. Electroacupuncture may also alleviate the symptoms of MA addiction such as psychosis, anxiety, and depression during abstinence. However, several comorbidities are associated with MA use, such as blood-borne infections, decreased the willingness of physicians to perform. The advantages of laser acupuncture (LA) include its safety, painlessness, limited time use, and higher acceptability, making it suitable for treatment of drug users. To investigate the clinical efficacy of laser acupuncture combined with group cognitive behavioral therapy for MA addiction treatment. MA users who participated in group cognitive behavioral therapy and met the inclusion criteria were referred from psychiatrists to participate. The participants received laser acupuncture treatment once a week for 2 months (total eight treatments) on selected acupoints (PC6, HT7, LI4, ST36, SP6, and LR3). Laboratory assessment included urinalysis for MA and liver function tests aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltransferase (AST, ALT, and r-GT), whereas the objective assessment included visual analog scale (VAS) for MA craving and refusal and Pittsburgh sleep quality index (PSQI), Beck Anxiety Inventory (BAI), and Beck Depression Inventory (BDI) questionnaires. All data were collected before and at 1 and 2 months after treatment. Cognitive behavioral therapy completion rate and rate of relapse to MA use were also determined.

Official Title
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Positive Effects of Laser Acupuncture in Methamphetamine Users Undergoing Group Cognitive Behavioral Therapy: A Pilot Study

Conditions
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Substance Abuse

Intervention / Treatment
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* Device: Laser acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject must be aged ≥20 years, with full understanding of the content of the study and who signed a consent form subject must be diagnosed as MA use disorder by a psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) subject must participate in cognitive behavioral therapy Exclusion Criteria: subject received manual acupuncture or LA treatment in the preceding month subject had cancer, stroke, myocardial infarction, or major trauma subject demonstrated obvious suicide intention subject were pregnant subject were HIV-positive

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Because of uncertainty of effectiveness of laser acupuncture and drop out rate of MA users, investigators make an observational single group of pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser acupuncture group<br>Laser acupuncture group receive laser acupuncture treatment with cognitive behavioral therapy. | Device: Laser acupuncture<br>* The interventional group receive laser acupuncture applied on acupoints of PC6 (Neiguan), HT7 (Shenmen), LI4 (Hegu), ST36 (Zusanli), SP6 (Sanyinjiao), and LR3 (Taichong).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Aspartate aminotransferase (AST) | To detect liver damage. | change from baseline AST at 4 weeks and 8 weeks post-treatment | 
| Change of Alanine aminotransferase (ALT) | To detect liver damage. | change from baseline ALT at 4 weeks and 8 weeks post-treatment | 
| Change of γ-glutamyltransferase (γ-GT) | To detect liver damage. | change from baseline γ-GT at 4 weeks and 8 weeks post-treatment | 
| Change of Amphetamine confirm test | To confirm drug exposure involving amphetamines. | change from baseline Amphetamine at 4 weeks and 8 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Visual analog scale (VAS) | Evaluation of MA craving and refusal from 0 to 10. | change from baseline VAS at 4 weeks and 8 weeks post-treatment | 
| Change of Pittsburgh sleep quality index (PSQI) | Evaluation of sleep quality. | change from baseline PSQI at 4 weeks and 8 weeks post-treatment | 
| Change of Beck Anxiety Inventory (BAI) | Evaluation the degree of anxiety. | change from baseline BAI at 4 weeks and 8 weeks post-treatment | 
| Change of Beck Depression Inventory (BDI) | Evaluation the degree of depression. | change from baseline BDI at 4 weeks and 8 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance abuse, Methamphetamine addiction, Laser acupuncture