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Light Needle for Opioid Use Disorder (OUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05341219
Recruitment Status : Recruiting
First Posted : April 22, 2022
Last Update Posted : May 3, 2023
Sponsor:
Collaborator:
Kaohsiung Medical University
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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Brief Summary:
This randomized-controlled study investigates the effect of adjuvant light needle in the treatment of heroin addicts. One hundred heroin addicts older than 20 years old enrolled from the Addiction Treatment Center at Kaohsiung Chang Gung Memorial Hospital and Department of Psychiatry at Kaohsiung Medical University Hospital are randomly allocated to experimental or control group. Subjects in experimental group are treated with light needle on the wrist pulse (Cunkou) 12 times within 4 weeks. Subjects in the control group received a sham light needle treatment, without any laser output. Outcome measurements include check of urine morphine, report of the subjects' times or days of heroin use, self-filling Visual Analogue Scales of heroin craving / refusal of heroin use (0-10 points) during last week, report of the subjects' quality of life using Short Form-12v2, and record of the subject's pulse diagnosis and heart rate variability before and after treatment.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Procedure: Light needle therapy Procedure: Sham light needle therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects recruited from the two institutions are being randomly allocated to the experimental group (light needle plus methadone maintenance treatment, n = 50, expected), or the control group (light needle without laser output plus methadone maintenance treatment, n = 50, expected). The study participants will receive 12 sessions of light needle therapy within 4 weeks.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Allocation concealment was implemented through the use of numbered containers. The allocation sequence was concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed, and stapled envelopes. The trial participants, outcome assessors, and data analysts will be blinded after assignment to interventions using label A and B for the two groups.
Primary Purpose: Treatment
Official Title: Effect of Light Needle in the Treatment of Opioid Use Disorder: A Randomized Controlled Trial
Actual Study Start Date : March 18, 2022
Estimated Primary Completion Date : February 14, 2024
Estimated Study Completion Date : February 14, 2024
Arms and Interventions
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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.
 Procedure: 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.
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.
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. urinary morphine levels [ Time Frame: 4 weeks ]
    morphine levels in urine

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. self-reported quality of life using the Short Form-12v2® [ Time Frame: 4 weeks ]
    The PRO CoRE will be used to score the SF-12v2 Health Survey.

  3. pulse diagnosis and heart rate variability [ Time Frame: 4 weeks ]
    pulse diagnosis and heart rate variability will be recorded.


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

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.
Contacts and Locations
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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): NCT05341219


Contacts
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Contact: Cheng-Yi Chang +886-3-3196200 ext 3713 ccyi@cgmh.org.tw
Contact: Mer-Lin Chi +886-3-3196200 ext 3702 merlinchi@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 2335    oolonghu@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Kaohsiung Medical University
Investigators
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Principal Investigator: Wen-Long Hu, MD, MS Chief, Division of Acupuncture, Kaohsiung Chang Gung Memorial Hospital
More Information
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT05341219    
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 )
First Posted: April 22, 2022    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023

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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:
Light needle
Opioid use disorder
Heroin addiction
Methadone maintenance treatment
Traditional Chinese medicine
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Substance-Related Disorders
Pathologic Processes
 Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders