Light Needle for Opioid Use Disorder (OUD)
Effect of Light Needle in the Treatment of Opioid Use Disorder: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Heroin addiction remains a significant public health problem worldwide, and relapse to heroin use following cessation of agonist maintenance treatment is common. The problems associated with use of opioid agonists mean that non-opioid therapies need to be developed to ameliorate acute and protracted opioid withdrawal syndromes.
Objective: To investigate the effect of adjuvant light needle therapy in patients with opioid use disorder on methadone maintenance treatment.
Methods: One hundred participants with opioid use disorder on methadone maintenance treatment will be enrolled from the addiction treatment center at Kaohsiung Chang Gung Memorial Hospital and Department of Psychiatry at Kaohsiung Medical University Hospital, and randomly allocated to the experimental or control group. The experimental group is receiving 12 sessions of light needle therapy within 4 weeks. The control group is receiving sham light needle treatment, without any laser output. Urinary morphine levels are being checked before and after treatment. Subjects are requested to self-report their number of episodes or days of heroin use and 0-10-point visual analogue scale scores for heroin craving/refusal to use heroin during the previous week before and after treatment. Quality of life will be reported using the Short Form-12v2 before and after 4 weeks of treatment. Pulse diagnosis will be recorded and heart rate variability calculated before and after treatment. The baseline patient characteristics will be compared between the experimental and control groups using the independent t-test and chi-square test. Data are compared between the two groups using repeated-measures analysis of variance, generalized estimating equations, and the paired t-test.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mer-Lin Chi
- Phone Number: 3702 +886-3-3196200
- Email: merlinchi@cgmh.org.tw
Study Locations
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-
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Kaohsiung, Taiwan, 833
- Recruiting
- Kaohsiung Chang Gung Memorial Hospital
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Contact:
- Wen-Long Hu, MD, MS
- Phone Number: 2335 +886-7-7317123
- Email: oolonghu@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A diagnosis of OUD is confirmed using the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Subjects aged 20-70 years with OUD who have received methadone maintenance treatment for at least 1 month and provided informed consent are being recruited. Psychiatrists assess each prospective participant's eligibility to be enrolled in the study.
Exclusion Criteria:
- Subjects with a critical illness
- those who have taken Chinese herbs or received acupuncture treatment during the previous 30 days
- those who are unsuitable for recruitment in the opinion of the attending physician
- those who are unwilling to provide informed consent are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: light needle therapy
The study participants will receive 12 sessions of light needle therapy within 4 weeks using a gallium aluminum arsenide Physiolaser olympic (maximal power, 60mW; wavelength, 655 nm; area of probe, 0.008 cm2; power density, 7.5 W/cm2; pulsed-wave; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany).
Those in the experimental group received a total 135 J of energy delivered from 6 light needles being placed between LU7 and LU9.
The light needle therapy was applied to each point for 15 min.
|
The study participants will receive 12 sessions of light needle therapy within 4 weeks using a gallium aluminum arsenide Physiolaser olympic (maximal power, 60mW; wavelength, 655 nm; area of probe, 0.008 cm2; power density, 7.5 W/cm2; pulsed-wave; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany).
Those in the experimental group received a total 135 J of energy delivered from 6 light needles being placed between LU7 and LU9.
The light needle therapy was applied to each point for 15 min.
|
|
Sham Comparator: sham light needle therapy
The study participants will receive 12 sessions of sham light needle therapy, without any laser output (no stimulation), within 4 weeks using a gallium aluminum arsenide Physiolaser olympic.
Those in the control group received 0 J of energy delivered from 6 light needles being placed between LU7 and LU9 for 15 min.
|
The study participants will receive 12 sessions of sham light needle therapy, without any laser output (no stimulation), within 4 weeks using a gallium aluminum arsenide Physiolaser olympic.
Those in the control group received 0 J of energy delivered from 6 light needles being placed between LU7 and LU9 for 15 min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
urinary morphine levels
Time Frame: 4 weeks
|
morphine levels in urine
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4 weeks
|
|
times or days of heroin use during the previous week
Time Frame: 4 weeks
|
self-reported times or days of heroin use during the previous week
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-reported visual analogue scale (VAS) scores for heroin craving/refusal to use heroin (0-10 points) in the previous week
Time Frame: 4 weeks
|
A VAS score of 0 for heroin craving indicates no heroin craving and a score of 10 indicates the strongest possible heroin craving.
A VAS score of 0 for refusal to use heroin indicates no refusal and a score of 10 indicates total refusal.
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4 weeks
|
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self-reported quality of life using the Short Form-12v2®
Time Frame: 4 weeks
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The PRO CoRE will be used to score the SF-12v2 Health Survey.
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4 weeks
|
|
pulse diagnosis and heart rate variability
Time Frame: 4 weeks
|
pulse diagnosis and heart rate variability will be recorded.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wen-Long Hu, MD, MS, Chief, Division of Acupuncture, Kaohsiung Chang Gung Memorial Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMRPG8M0031
- MOHW111-CMAP-M-113-112103 (Other Grant/Funding Number: The Ministry of Health and Welfare)
- MOHW112-CMAP-M-113-000005-C (Other Grant/Funding Number: The Ministry of Health and Welfare)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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