NCT04003077

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

June 1, 2019

Enrollment Period

1.1 years

First QC Date

June 18, 2019

Last Update Submit

March 13, 2020

Conditions

Heroin Dependence

Keywords

Laser meridian massageheroin addictsmethadone treatmenttraditional Chinese medicine

Outcome Measures

Primary Outcomes (4)

  • Heroin use

    Times or days of heroin use during last week

    2 weeks of treatment

  • Heroin use

    Times or days of heroin use during last week

    4 weeks of treatment

  • Urine morphine

    Obtainurinary morphine concentration

    2 weeks of treatment

  • Urine morphine

    Obtain urinary morphine concentration

    4 weeks of treatment

Secondary Outcomes (3)

  • Heroin craving / refusal of heroin use

    2 weeks of treatment

  • Heroin craving / refusal of heroin use

    4 weeks of treatment

  • Short Form-12v2 Health Survey

    4 weeks of treatment

Study Arms (2)

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.

Device: laser meridian massage

Control

NO INTERVENTION

A control group of participants without laser meridian massage treatment are matched by age.

Interventions

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.

Laser meridian massage

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31574863DERIVED

MeSH Terms

Conditions

Heroin Dependence

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Cheng-Yi Chang

CONTACT

+886-3-3196200ccyi@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: observational case-controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

July 1, 2019

Study Start

February 26, 2019

Primary Completion

April 16, 2020

Study Completion

April 16, 2020

Last Updated

March 16, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)