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Laser Meridian Massage in Heroin Addicts

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ClinicalTrials.gov Identifier: NCT04003077
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Heroin Dependence Device: laser meridian massage Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: observational case-controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Laser Meridian Massage in Heroin Addicts With Methadone Treatment: an Observational Case-controlled Study
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Arm Intervention/treatment
Experimental: Laser meridian massage
They are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks.
Device: laser meridian massage
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.

No Intervention: Control
A control group of participants without laser meridian massage treatment are matched by age.



Primary Outcome Measures :
  1. Heroin use [ Time Frame: 2 weeks of treatment ]
    Times or days of heroin use during last week

  2. Heroin use [ Time Frame: 4 weeks of treatment ]
    Times or days of heroin use during last week

  3. Urine morphine [ Time Frame: 2 weeks of treatment ]
    Obtainurinary morphine concentration

  4. Urine morphine [ Time Frame: 4 weeks of treatment ]
    Obtain urinary morphine concentration


Secondary Outcome Measures :
  1. Heroin craving / refusal of heroin use [ Time Frame: 2 weeks of treatment ]
    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.

  2. Heroin craving / refusal of heroin use [ Time Frame: 4 weeks of treatment ]
    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.

  3. Short Form-12v2 Health Survey [ Time Frame: 4 weeks of treatment ]

    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.




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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003077


Contacts
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Contact: Cheng-Yi Chang +886-3-3196200 ext 3713 ccyi@cgmh.org.tw

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: Wen-Long Hu, MD, MS    +886-7-7317123 ext 6255    oolonghu@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Health and Welfare, Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04003077     History of Changes
Other Study ID Numbers: PMRPG8J0081
M08G1056 ( Other Grant/Funding Number: Ministry of Health and Welfare )
201801823A3 ( Other Identifier: Chang Gung Medical Foundation Institutional Review Board )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Laser meridian massage
heroin addicts
methadone treatment
traditional Chinese medicine
Additional relevant MeSH terms:
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Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Heroin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents