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Clinical Trials/NCT04789772
NCT04789772UnknownNot Applicable

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

Chang Gung Memorial Hospital4 sites in 1 country15 target enrollmentStarted: May 11, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
15
Locations
4
Primary Endpoint
Change of γ-glutamyltransferase (γ-GT)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change of γ-glutamyltransferase (γ-GT)

Time Frame: change from baseline γ-GT at 4 weeks and 8 weeks post-treatment

To detect liver damage.

Change of Aspartate aminotransferase (AST)

Time Frame: change from baseline AST at 4 weeks and 8 weeks post-treatment

To detect liver damage.

Change of Alanine aminotransferase (ALT)

Time Frame: change from baseline ALT at 4 weeks and 8 weeks post-treatment

To detect liver damage.

Change of Amphetamine confirm test

Time Frame: change from baseline Amphetamine at 4 weeks and 8 weeks post-treatment

To confirm drug exposure involving amphetamines.

Secondary Outcomes

  • Change of Beck Anxiety Inventory (BAI)(change from baseline BAI at 4 weeks and 8 weeks post-treatment)
  • Change of Visual analog scale (VAS)(change from baseline VAS at 4 weeks and 8 weeks post-treatment)
  • Change of Beck Depression Inventory (BDI)(change from baseline BDI at 4 weeks and 8 weeks post-treatment)
  • Change of Pittsburgh sleep quality index (PSQI)(change from baseline PSQI at 4 weeks and 8 weeks post-treatment)

Investigators

Sponsor
Chang Gung Memorial Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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