Clinical trial NCT04003077: Laser Meridian Massage in Heroin Addicts
Official title: Adjuvant Laser Meridian Massage in Heroin Addicts With Methadone Treatment: an Observational Case-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heroin Dependence
Keywords: Laser meridian massage
heroin addicts
methadone treatment
traditional Chinese medicine
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2019-07-01
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: observational case-controlled study
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Heroin use
timeFrame: 2 weeks of treatment
measure: Heroin use
timeFrame: 4 weeks of treatment
measure: Urine morphine
timeFrame: 2 weeks of treatment
measure: Urine morphine
timeFrame: 4 weeks of treatment
Secondary outcomes:
measure: Heroin craving / refusal of heroin use
timeFrame: 2 weeks of treatment
measure: Heroin craving / refusal of heroin use
timeFrame: 4 weeks of treatment
measure: Short Form-12v2 Health Survey
timeFrame: 4 weeks of treatment
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
citation: 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.