Heroin DependenceNCT04003077
Laser Meridian Massage in Heroin Addicts
A study testing laser meridian massage in people with Heroin Dependence, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A case-controlled study is conducted to investigate the effect of adjuvant laser meridian massage in heroin addicts with methadone treatment and establish the model of laser meridian massage treatment for drug addiction. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Heroin Dependence
- What is being tested?
- laser meridian massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2019to 16 Apr 2020
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide informed consent
- Male older than 20 years
- Diagnosed with opioid use disorder according to DSM-5 and received methadone treatment more than 1 month
Who cannot join
- Received Antidepressant or antipsychotic
- Received Chinese herb or acupuncture treatment during last 30 days
- Critical illness
- Did not meet the physician's assessment for recruitment
- Patients with Human immunodeficiency virus infection
- Did not provide informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Wen-Long Hu, MD, MS, +886-7-7317123 ext. 6255, oolonghu@gmail.com
About this study
Official title: Adjuvant Laser Meridian Massage in Heroin Addicts With Methadone Treatment: an Observational Case-controlled Study
A case-controlled study is conducted to investigate the effect of adjuvant laser meridian massage in heroin addicts with methadone treatment and establish the model of laser meridian massage treatment for drug addiction.
Read the detailed description
Objective: To investigate the effect of adjuvant laser meridian massage in heroin addicts with methadone treatment and establish the model of laser meridian massage treatment for drug addiction.
Methods: A case-controlled study is conducted. Fifteen male heroin addicts are enrolled from Addiction Treatment Center as treatment group. They are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks. A control group of participants without laser meridian massage treatment are matched by age. Check urine morphine before, 2 and 4 weeks of treatment. Subjects report their times or days of heroin use and self-fill Visual Analogue Scales of heroin craving / refusal of heroin use (0-10 points) during last week before, 2 and 4 weeks of treatment. Subjects report their quality of life using Short Form-12v2 before and 4 weeks of treatment. Obtain the subject's pulse diagnosis and heart rate variability after a single treatment. Independent t test, Mann-Whitney U test, chi-square test and Fisher's exact test were used to compare the differences between the treatment and control groups. Repeated measures ANOVA, Generalized estimating equations, paired t test and Wilcoxon Signed-Rank test were used for comparison between the treatment and control groups.
- Conditions
- Heroin Dependence
- Being tested
- laser meridian massage
- Keywords
- Laser meridian massage, heroin addicts, methadone treatment, traditional Chinese medicine
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser meridian massageDevice
The participants will undergo 12 sessions of laser meridian massage, thrice a week, for 4 weeks, using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810nm; area of probe, 0.5cm^2; power density, 300mW/cm^2; pulsed wave; RJ-Laser, Reimers \& Janssen GmbH, Waldkirch, Germany). The laser treatment will be applied to the back including Bladder meridian (BL11-25) and Governor vessel (GV3-14) for 15 minutes, to deliver a total treatment dose of 67.5J/cm^2.
| Study group | Role | What they receive |
|---|---|---|
| Laser meridian massage | Experimental | They are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks. Receives: Device: laser meridian massage |
| Control | No intervention | A control group of participants without laser meridian massage treatment are matched by age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heroin use
Times or days of heroin use during last week
Measured: 2 weeks of treatment
Heroin use
Times or days of heroin use during last week
Measured: 4 weeks of treatment
Urine morphine
Obtainurinary morphine concentration
Measured: 2 weeks of treatment
Urine morphine
Obtain urinary morphine concentration
Measured: 4 weeks of treatment
Secondary outcomes (3)
Heroin craving / refusal of heroin use
Obtain Visual Analogue Scales (VAS) of heroin craving / refusal of heroin use (0-10 points) during last week. VAS score 0 of heroin craving indicates no heroin craving, while VAS 10 indicates strongest heroin craving. VAS 0 of refusal of heroin use indicates no refusal of heroin, while VAS 10 indicates absolute refusal of heroin.
Measured: 2 weeks of treatment
Heroin craving / refusal of heroin use
Obtain Visual Analogue Scales (VAS) of heroin craving / refusal of heroin use (0-10 points) during last week. VAS score 0 of heroin craving indicates no heroin craving, while VAS 10 indicates strongest heroin craving. VAS 0 of refusal of heroin use indicates no refusal of heroin, while VAS 10 indicates absolute refusal of heroin.
Measured: 4 weeks of treatment
Short Form-12v2 Health Survey
The SF-12v2® Health Survey (SF-12v2) is a multipurpose, short-form health survey with 12 questions that yields an eight-scale profile of functional health and well-being, as well as two psychometrically based physical and mental health summary measures and a preference-based health utility index.
The PRO CoRE, part of the Smart Measurement® System suite of products and Optum's upgrade to the QualityMetric Health Outcomes™ Scoring Software, is used for scoring the SF-12v2® Health Survey.
Measured: 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start26 Feb 2019
- Primary completion16 Apr 2020 (estimated)
- Study completion16 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- observational case-controlled study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003077
- Sponsor's protocol ID
- PMRPG8J0081
- Other IDs
- M08G1056, 201801823A3
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu WL, Tsai MC, Kuo CE, Liu CT, Wu SY, Wu TC, Hung YC. Adjuvant laser meridian massage in men with opioid use disorder on methadone maintenance treatment: Protocol for a case-controlled study. Medicine (Baltimore). 2019 Sep;98(39):e17319. doi: 10.1097/MD.0000000000017319.
PubMed 31574863
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Laser Meridian Massage in Heroin Addicts With Methadone Treatment: an Observational Case-controlled Study
- ClinicalTrials.gov ID
- NCT04003077
- Acronym / sponsor ID
- PMRPG8J0081
- Conditions
- Heroin Dependence
- Keywords
- Laser meridian massage, heroin addicts, methadone treatment, traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 16 Apr 2020 (estimated)
- Study completion
- 16 Apr 2020 (estimated)
- First posted
- 1 Jul 2019 (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.
A case-controlled study is conducted to investigate the effect of adjuvant laser meridian massage in heroin addicts with methadone treatment and establish the model of laser meridian massage treatment for drug addiction.
Detailed description
Objective: To investigate the effect of adjuvant laser meridian massage in heroin addicts with methadone treatment and establish the model of laser meridian massage treatment for drug addiction.
Methods: A case-controlled study is conducted. Fifteen male heroin addicts are enrolled from Addiction Treatment Center as treatment group. They are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks. A control group of participants without laser meridian massage treatment are matched by age. Check urine morphine before, 2 and 4 weeks of treatment. Subjects report their times or days of heroin use and self-fill Visual Analogue Scales of heroin craving / refusal of heroin use (0-10 points) during last week before, 2 and 4 weeks of treatment. Subjects report their quality of life using Short Form-12v2 before and 4 weeks of treatment. Obtain the subject's pulse diagnosis and heart rate variability after a single treatment. Independent t test, Mann-Whitney U test, chi-square test and Fisher's exact test were used to compare the differences between the treatment and control groups. Repeated measures ANOVA, Generalized estimating equations, paired t test and Wilcoxon Signed-Rank test were used for comparison between the treatment and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- observational case-controlled study
| Arm | Type | Receives |
|---|---|---|
| Laser meridian massage | Experimental | Device: laser meridian massageThey are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks. |
| Control | No intervention | –A control group of participants without laser meridian massage treatment are matched by age. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide informed consent
- Male older than 20 years
- Diagnosed with opioid use disorder according to DSM-5 and received methadone treatment more than 1 month
Key exclusion criteria (6 listed)
- Received Antidepressant or antipsychotic
- Received Chinese herb or acupuncture treatment during last 30 days
- Critical illness
- Did not meet the physician's assessment for recruitment
- Patients with Human immunodeficiency virus infection
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 meridian massageThe participants will undergo 12 sessions of laser meridian massage, thrice a week, for 4 weeks, using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810nm; area of probe, 0.5cm^2; power density, 300mW/cm^2; pulsed wave; RJ-Laser, Reimers \& Janssen GmbH, Waldkirch, Germany). The laser treatment will be applied to the back including Bladder meridian (BL11-25) and Governor vessel (GV3-14) for 15 minutes, to deliver a total treatment dose of 67.5J/cm^2. | Device | Laser meridian massage |
Primary outcome
Heroin use
Time frame: 2 weeks of treatment
Times or days of heroin use during last week
Heroin use
Time frame: 4 weeks of treatment
Times or days of heroin use during last week
Urine morphine
Time frame: 2 weeks of treatment
Obtainurinary morphine concentration
Urine morphine
Time frame: 4 weeks of treatment
Obtain urinary morphine concentration
3 secondary outcomes
Heroin craving / refusal of heroin use
Time frame: 2 weeks of treatment
Heroin craving / refusal of heroin use
Time frame: 4 weeks of treatment
Short Form-12v2 Health Survey
Time frame: 4 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Derived from this study: PubMed 31574863Hu WL, Tsai MC, Kuo CE, Liu CT, Wu SY, Wu TC, Hung YC. Adjuvant laser meridian massage in men with opioid use disorder on methadone maintenance treatment: Protocol for a case-controlled study. Medicine (Baltimore). 2019 Sep;98(39):e17319. doi: 10.1097/MD.0000000000017319.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser meridian massage in people with Heroin Dependence, run by Chang Gung Memorial Hospital at 1 site 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 6 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 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Cheng-Yi Chang (+886-3-3196200 ext. 3713, ccyi@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heroin use (time frame: 2 weeks of 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?
On the ClinicalTrials.gov record for NCT04003077, which also lists 1 linked publication.
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 16 Mar 2020.