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

NCT ID: NCT04789772

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-11

Study Completion Date

2021-12-25

Brief Summary

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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

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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.

Conditions

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Substance Abuse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser acupuncture group

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

Group Type EXPERIMENTAL

Laser acupuncture

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health and Welfare

AMBIG

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center for traditional chinese medicine, Chang Gung Memorial Hospital

Guishan Dist, Taoyuan County, Taiwan

Site Status RECRUITING

TSE-HUNG HUANG MD PhD

Keelung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Tse-Hung Huang, M.D.

Role: primary

+886-3196200 ext. 2613

TSE-HUNG HUANG

Role: primary

+886-3196200 ext. 2613

Other Identifiers

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201800431A3

Identifier Type: -

Identifier Source: org_study_id

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