Substance AbuseNCT04789772
Positive Effects of Laser Acupuncture in Methamphetamine Users Undergoing Group Cognitive Behavioral Therapy: A Pilot Study
A study testing Laser acupuncture in people with Substance Abuse, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesTaiwan
- Study dates
- 11 May 2018to 25 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Center for traditional chinese medicine, Chang Gung Memorial Hospital
Guishan Dist, Taoyuan County, 33378
Tse-Hung Huang, M.D., +886-3196200 ext. 2613, huangtsehung@gmail.com
Tse-Hung Huang, M.D.
- Recruiting
TSE-HUNG HUANG MD PhD
Keelung, 204
TSE-HUNG HUANG, +886-3196200 ext. 2613, huangtsehung@gmail.com
About this study
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.
Read the 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.
- Conditions
- Substance Abuse
- Being tested
- Laser acupuncture
- Keywords
- Substance abuse, Methamphetamine addiction, Laser acupuncture
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture group | Experimental | Laser acupuncture group receive laser acupuncture treatment with cognitive behavioral therapy. Receives: Device: Laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Aspartate aminotransferase (AST)
To detect liver damage.
Measured: change from baseline AST at 4 weeks and 8 weeks post-treatment
Change of Alanine aminotransferase (ALT)
To detect liver damage.
Measured: change from baseline ALT at 4 weeks and 8 weeks post-treatment
Change of γ-glutamyltransferase (γ-GT)
To detect liver damage.
Measured: change from baseline γ-GT at 4 weeks and 8 weeks post-treatment
Change of Amphetamine confirm test
To confirm drug exposure involving amphetamines.
Measured: change from baseline Amphetamine at 4 weeks and 8 weeks post-treatment
Secondary outcomes (4)
Change of Visual analog scale (VAS)
Evaluation of MA craving and refusal from 0 to 10.
Measured: change from baseline VAS at 4 weeks and 8 weeks post-treatment
Change of Pittsburgh sleep quality index (PSQI)
Evaluation of sleep quality.
Measured: change from baseline PSQI at 4 weeks and 8 weeks post-treatment
Change of Beck Anxiety Inventory (BAI)
Evaluation the degree of anxiety.
Measured: change from baseline BAI at 4 weeks and 8 weeks post-treatment
Change of Beck Depression Inventory (BDI)
Evaluation the degree of depression.
Measured: change from baseline BDI at 4 weeks and 8 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start11 May 2018
- Primary completion25 Dec 2018
- Study completion25 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789772
- Sponsor's protocol ID
- 201800431A3
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Effects of Laser Acupuncture in Methamphetamine Users Undergoing Group Cognitive Behavioral Therapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT04789772
- Acronym / sponsor ID
- 201800431A3
- Conditions
- Substance Abuse
- Keywords
- Substance abuse, Methamphetamine addiction, Laser acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare
- Study start
- 11 May 2018 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 25 Dec 2021 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture group | Experimental | Device: Laser acupunctureLaser acupuncture group receive laser acupuncture treatment with cognitive behavioral therapy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupunctureThe interventional group receive laser acupuncture applied on acupoints of PC6 (Neiguan), HT7 (Shenmen), LI4 (Hegu), ST36 (Zusanli), SP6 (Sanyinjiao), and LR3 (Taichong). | Device | Laser acupuncture group |
Primary outcome
Change of Aspartate aminotransferase (AST)
Time frame: change from baseline AST at 4 weeks and 8 weeks post-treatment
To detect liver damage.
Change of Alanine aminotransferase (ALT)
Time frame: change from baseline ALT at 4 weeks and 8 weeks post-treatment
To detect liver damage.
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 of Amphetamine confirm test
Time frame: change from baseline Amphetamine at 4 weeks and 8 weeks post-treatment
To confirm drug exposure involving amphetamines.
4 secondary outcomes
Change of Visual analog scale (VAS)
Time frame: 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
Change of Beck Anxiety Inventory (BAI)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Center for traditional chinese medicine, Chang Gung Memorial Hospital
Guishan Dist, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture in people with Substance Abuse, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Aspartate aminotransferase (AST) (time frame: change from baseline AST at 4 weeks and 8 weeks post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.