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

Primary Purpose

Substance Abuse

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Substance abuse, Methamphetamine addiction, Laser acupuncture

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for traditional chinese medicine, Chang Gung Memorial HospitalRecruiting
  • TSE-HUNG HUANG MD PhDRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser acupuncture group

Arm Description

Laser acupuncture group receive laser acupuncture treatment with cognitive behavioral therapy.

Outcomes

Primary Outcome Measures

Change of Aspartate aminotransferase (AST)
To detect liver damage.
Change of Alanine aminotransferase (ALT)
To detect liver damage.
Change of γ-glutamyltransferase (γ-GT)
To detect liver damage.
Change of Amphetamine confirm test
To confirm drug exposure involving amphetamines.

Secondary Outcome Measures

Change of Visual analog scale (VAS)
Evaluation of MA craving and refusal from 0 to 10.
Change of Pittsburgh sleep quality index (PSQI)
Evaluation of sleep quality.
Change of Beck Anxiety Inventory (BAI)
Evaluation the degree of anxiety.
Change of Beck Depression Inventory (BDI)
Evaluation the degree of depression.

Full Information

First Posted
March 5, 2021
Last Updated
March 7, 2021
Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Health and Welfare
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1. Study Identification

Unique Protocol Identification Number
NCT04789772
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
December 25, 2018 (Actual)
Study Completion Date
December 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Health and Welfare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Substance abuse, Methamphetamine addiction, Laser acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture group
Arm Type
Experimental
Arm Description
Laser acupuncture group receive laser acupuncture treatment with cognitive behavioral therapy.
Intervention Type
Device
Intervention Name(s)
Laser acupuncture
Intervention Description
The interventional group receive laser acupuncture applied on acupoints of PC6 (Neiguan), HT7 (Shenmen), LI4 (Hegu), ST36 (Zusanli), SP6 (Sanyinjiao), and LR3 (Taichong).
Primary Outcome Measure Information:
Title
Change of Aspartate aminotransferase (AST)
Description
To detect liver damage.
Time Frame
change from baseline AST at 4 weeks and 8 weeks post-treatment
Title
Change of Alanine aminotransferase (ALT)
Description
To detect liver damage.
Time Frame
change from baseline ALT at 4 weeks and 8 weeks post-treatment
Title
Change of γ-glutamyltransferase (γ-GT)
Description
To detect liver damage.
Time Frame
change from baseline γ-GT at 4 weeks and 8 weeks post-treatment
Title
Change of Amphetamine confirm test
Description
To confirm drug exposure involving amphetamines.
Time Frame
change from baseline Amphetamine at 4 weeks and 8 weeks post-treatment
Secondary Outcome Measure Information:
Title
Change of Visual analog scale (VAS)
Description
Evaluation of MA craving and refusal from 0 to 10.
Time Frame
change from baseline VAS at 4 weeks and 8 weeks post-treatment
Title
Change of Pittsburgh sleep quality index (PSQI)
Description
Evaluation of sleep quality.
Time Frame
change from baseline PSQI at 4 weeks and 8 weeks post-treatment
Title
Change of Beck Anxiety Inventory (BAI)
Description
Evaluation the degree of anxiety.
Time Frame
change from baseline BAI at 4 weeks and 8 weeks post-treatment
Title
Change of Beck Depression Inventory (BDI)
Description
Evaluation the degree of depression.
Time Frame
change from baseline BDI at 4 weeks and 8 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Center for traditional chinese medicine, Chang Gung Memorial Hospital
City
Guishan Dist
State/Province
Taoyuan County
ZIP/Postal Code
33378
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tse-Hung Huang, M.D.
Phone
+886-3196200
Ext
2613
Email
huangtsehung@gmail.com
First Name & Middle Initial & Last Name & Degree
Tse-Hung Huang, M.D.
Facility Name
TSE-HUNG HUANG MD PhD
City
Keelung
ZIP/Postal Code
204
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TSE-HUNG HUANG
Phone
+886-3196200
Ext
2613
Email
huangtsehung@gmail.com

12. IPD Sharing Statement

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

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