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

Substance Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04789772
• Other study ID #: 201800431A3
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: December 25, 2021

Study information

• Verified date: March 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 25, 2021
• Est. primary completion date: December 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

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).

Locations

Country	Name	City	State
Taiwan	Center for traditional chinese medicine, Chang Gung Memorial Hospital	Guishan Dist	Taoyuan County
Taiwan	TSE-HUNG HUANG MD PhD	Keelung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Aspartate aminotransferase (AST)	To detect liver damage.	change from baseline AST at 4 weeks and 8 weeks post-treatment
Primary	Change of Alanine aminotransferase (ALT)	To detect liver damage.	change from baseline ALT at 4 weeks and 8 weeks post-treatment
Primary	Change of ?-glutamyltransferase (?-GT)	To detect liver damage.	change from baseline ?-GT at 4 weeks and 8 weeks post-treatment
Primary	Change of Amphetamine confirm test	To confirm drug exposure involving amphetamines.	change from baseline Amphetamine at 4 weeks and 8 weeks post-treatment
Secondary	Change of Visual analog scale (VAS)	Evaluation of MA craving and refusal from 0 to 10.	change from baseline VAS at 4 weeks and 8 weeks post-treatment
Secondary	Change of Pittsburgh sleep quality index (PSQI)	Evaluation of sleep quality.	change from baseline PSQI at 4 weeks and 8 weeks post-treatment
Secondary	Change of Beck Anxiety Inventory (BAI)	Evaluation the degree of anxiety.	change from baseline BAI at 4 weeks and 8 weeks post-treatment
Secondary	Change of Beck Depression Inventory (BDI)	Evaluation the degree of depression.	change from baseline BDI at 4 weeks and 8 weeks post-treatment