Clinical trial NCT04789772: Positive Effects of Laser Acupuncture in Methamphetamine Users Undergoing Group Cognitive Behavioral Therapy: A Pilot Study
Official title: Positive Effects of Laser Acupuncture in Methamphetamine Users Undergoing Group Cognitive Behavioral Therapy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Abuse
Keywords: Substance abuse
Methamphetamine addiction
Laser acupuncture
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare
First posted: 2021-03-10
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Aspartate aminotransferase (AST)
timeFrame: change from baseline AST at 4 weeks and 8 weeks post-treatment
measure: Change of Alanine aminotransferase (ALT)
timeFrame: change from baseline ALT at 4 weeks and 8 weeks post-treatment
measure: Change of γ-glutamyltransferase (γ-GT)
timeFrame: change from baseline γ-GT at 4 weeks and 8 weeks post-treatment
measure: Change of Amphetamine confirm test
timeFrame: change from baseline Amphetamine at 4 weeks and 8 weeks post-treatment
Secondary outcomes:
measure: Change of Visual analog scale (VAS)
timeFrame: change from baseline VAS at 4 weeks and 8 weeks post-treatment
measure: Change of Pittsburgh sleep quality index (PSQI)
timeFrame: change from baseline PSQI at 4 weeks and 8 weeks post-treatment
measure: Change of Beck Anxiety Inventory (BAI)
timeFrame: change from baseline BAI at 4 weeks and 8 weeks post-treatment
measure: Change of Beck Depression Inventory (BDI)
timeFrame: change from baseline BDI at 4 weeks and 8 weeks post-treatment
Other outcomes:
Locations:
city: Guishan Dist
country: Taiwan
facility: Center for traditional chinese medicine, Chang Gung Memorial Hospital
state: Taoyuan County
city: Keelung
country: Taiwan
facility: TSE-HUNG HUANG MD PhD
Study officials:
References: