Opioid Use DisorderOUDNCT05341219
Light Needle for Opioid Use Disorder
A study testing Light needle therapy in people with Opioid Use Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Light needle therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Mar 2022to 14 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Wen-Long Hu, MD, MS, +886-7-7317123 ext. 2335, oolonghu@gmail.com
About this study
Official title: Effect of Light Needle in the Treatment of Opioid Use Disorder: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Light needle therapy, Sham light needle therapy
- Keywords
- Light needle, Opioid use disorder, Heroin addiction, Methadone maintenance treatment, Traditional Chinese medicine
- Medical subject headings
- Opioid-Related Disorders, Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light needle therapyProcedure or surgery
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 light needle therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham light needle therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary morphine levels
morphine levels in urine
Measured: 4 weeks
times or days of heroin use during the previous week
self-reported times or days of heroin use during the previous week
Measured: 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
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.
Measured: 4 weeks
self-reported quality of life using the Short Form-12v2®
The PRO CoRE will be used to score the SF-12v2 Health Survey.
Measured: 4 weeks
pulse diagnosis and heart rate variability
pulse diagnosis and heart rate variability will be recorded.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start18 Mar 2022
- Primary completion14 Feb 2024 (estimated)
- Study completion14 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Medical University
- Responsible party
- Sponsor
- Investigators
- Wen-Long Hu, MD, MS, Principal investigator, Chief, Division of Acupuncture, Kaohsiung Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341219
- Sponsor's protocol ID
- PMRPG8M0031
- Other IDs
- MOHW111-CMAP-M-113-112103, MOHW112-CMAP-M-113-000005-C
- Acronym
- OUD
- Status last verified
- May 2023
- First submitted
- 18 Apr 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Light Needle in the Treatment of Opioid Use Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05341219
- Acronym / sponsor ID
- OUD / PMRPG8M0031
- Conditions
- Opioid Use Disorder
- Keywords
- Light needle, Opioid use disorder, Heroin addiction, Methadone maintenance treatment, Traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Kaohsiung Medical University
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 14 Feb 2024 (estimated)
- Study completion
- 14 Feb 2024 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| light needle therapy | Experimental | Procedure: Light needle therapyThe 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 light needle therapy | Sham comparator | Procedure: Sham light needle therapyThe 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light needle therapyThe 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 or surgery | light needle therapy |
| Sham light needle therapyThe 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 or surgery | sham light needle therapy |
Primary outcome
urinary morphine levels
Time frame: 4 weeks
morphine levels in urine
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
3 secondary outcomes
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
self-reported quality of life using the Short Form-12v2®
Time frame: 4 weeks
pulse diagnosis and heart rate variability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Long Hu, MD, MS principal investigator
Chief, Division of Acupuncture, Kaohsiung Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light needle therapy in people with Opioid Use Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Yi Chang (+886-3-3196200 ext. 3713, ccyi@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary morphine levels (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.