NCT05341219

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.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

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

March 18, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

April 18, 2022

Last Update Submit

May 2, 2023

Conditions

Opioid Use Disorder

Keywords

Light needleOpioid use disorderHeroin addictionMethadone maintenance treatmentTraditional Chinese medicine

Outcome Measures

Primary Outcomes (2)

  • urinary morphine levels

    morphine levels in urine

    4 weeks

  • times or days of heroin use during the previous week

    self-reported times or days of heroin use during the previous week

    4 weeks

Secondary Outcomes (3)

  • self-reported visual analogue scale (VAS) scores for heroin craving/refusal to use heroin (0-10 points) in the previous week

    4 weeks

  • self-reported quality of life using the Short Form-12v2®

    4 weeks

  • pulse diagnosis and heart rate variability

    4 weeks

Study Arms (2)

light needle therapy

EXPERIMENTAL

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

sham light needle therapy

SHAM COMPARATOR

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

Interventions

Light needle therapyPROCEDURE

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.

light needle therapy
Sham light needle therapyPROCEDURE

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.

sham light needle therapy

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

MeSH Terms

Conditions

Opioid-Related DisordersHeroin Dependence

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Wen-Long Hu, MD, MS

    Chief, Division of Acupuncture, Kaohsiung Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Yi Chang

CONTACT

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

Mer-Lin Chi

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 22, 2022

Study Start

March 18, 2022

Primary Completion

February 14, 2024

Study Completion

February 14, 2024

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations

TW(1)