NCT04789772

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 5, 2021

Last Update Submit

March 7, 2021

Conditions

Substance Abuse

Keywords

Substance abuseMethamphetamine addictionLaser acupuncture

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Change of Visual analog scale (VAS)

    change from baseline VAS 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

  • Change of Beck Anxiety Inventory (BAI)

    change from baseline BAI 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

Study Arms (1)

Laser acupuncture group

EXPERIMENTAL

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

Device: Laser acupuncture

Interventions

Laser acupunctureDEVICE

The interventional group receive laser acupuncture applied on acupoints of PC6 (Neiguan), HT7 (Shenmen), LI4 (Hegu), ST36 (Zusanli), SP6 (Sanyinjiao), and LR3 (Taichong).

Laser acupuncture group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for traditional chinese medicine, Chang Gung Memorial Hospital

Guishan Dist, Taoyuan County, 33378, Taiwan

RECRUITING

TSE-HUNG HUANG MD PhD

Keelung, 204, Taiwan

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Because of uncertainty of effectiveness of laser acupuncture and drop out rate of MA users, investigators make an observational single group of pilot study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 10, 2021

Study Start

May 11, 2018

Primary Completion

December 25, 2018

Study Completion

December 25, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

TW(2)