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

March 7, 2021 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Keelung, Taiwan, 204
        • Recruiting
        • TSE-HUNG HUANG MD PhD
        • Contact:
    • Taoyuan County
      • Guishan Dist, Taoyuan County, Taiwan, 33378
        • Recruiting
        • Center for traditional chinese medicine, Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Aspartate aminotransferase (AST)
Time Frame: change from baseline AST at 4 weeks and 8 weeks post-treatment
To detect liver damage.
change from baseline AST at 4 weeks and 8 weeks post-treatment
Change of Alanine aminotransferase (ALT)
Time Frame: change from baseline ALT at 4 weeks and 8 weeks post-treatment
To detect liver damage.
change from baseline ALT at 4 weeks and 8 weeks post-treatment
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 from baseline γ-GT at 4 weeks and 8 weeks post-treatment
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.
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)
Time Frame: change from baseline VAS at 4 weeks and 8 weeks post-treatment
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)
Time Frame: change from baseline PSQI at 4 weeks and 8 weeks post-treatment
Evaluation of sleep quality.
change from baseline PSQI at 4 weeks and 8 weeks post-treatment
Change of Beck Anxiety Inventory (BAI)
Time Frame: change from baseline BAI at 4 weeks and 8 weeks post-treatment
Evaluation the degree of anxiety.
change from baseline BAI at 4 weeks and 8 weeks post-treatment
Change of Beck Depression Inventory (BDI)
Time Frame: change from baseline BDI at 4 weeks and 8 weeks post-treatment
Evaluation the degree of depression.
change from baseline BDI at 4 weeks and 8 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Health and Welfare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2018

Primary Completion (Actual)

December 25, 2018

Study Completion (Anticipated)

December 25, 2021

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 7, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 7, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201800431A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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