Opiate Withdrawal SyndromeAAMTHNCT03012373
Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
A study testing Ear acupressure alone and Electroacupuncture plus ear acupressure in people with Opiate Withdrawal Syndrome, run by Lu-Tung Christian Hospital at 1 site in Taiwan.
Trial summary
This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy both combined with methadone treatment services for heroin addicts. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Opiate Withdrawal Syndrome
- What is being tested?
- Ear acupressure alone and Electroacupuncture plus ear acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2016to 30 May 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for Opioid Use Disorder and had been received methadone maintenance treatment for more then one month.
Who cannot join
- had taking acupuncture treatment in past 30 days
- had severe adverse effects or events history from receiving acupuncture treatment
- had any serious physical illness
- had a significant risk of suicide
- ear infection
- were pregnant or or a woman plan to pregnant
- had bleeding disorders or were taking anticoagulant drugs
- had epilepsy, cerebral vascular disease and brain injured history.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy both combined with methadone treatment services for heroin addicts.
Read the detailed description
Methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on Methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years. Therefore, adjuvant therapeutic interventions for heroin addiction patients are needed. Since 1996, the World Health Organization (WHO) has classified acupuncture treatment indications, including drug abuse. The purpose of this study is to compare the difference of efficacy between ear acupressure alone and ear acupressure plus electrical acupuncture therapy both combined with standard methadone maintenance therapy to the heroin addicts.
Patients who receive methadone were randomly assigned to sequence A and B. Sequence A(n=20) receive ear Acupressure combined with electroacupuncture for four weeks, followed by one week wash-out period. Then ear acupressure alone for another four weeks.
Sequence B(n=20) receive EAR acupressure alone for four weeks first, and followed by one week wash-out period, then ear acupressure combined with electroacupuncture for another four weeks. Measures of methadone dosage and using the craving visual analog scale (VAS) to assess the craving severity for 8 weeks. Using the Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) to assess improvement of life quality and sleep quality. Using Beck anxiety and Depression inventory to evaluate emotional problems. Urine opiate screenings are provided after 4 weeks , 8 weeks treatment and 1 month after end of treatment, to screen opiate reuse.
The study hypothesis was acupuncture had more clinical efficacy than ear acupressure upon craving severity, life quality, mood stability ,reduced methadone dosage and sleep quality when provided as an adjunct to a standard methadone maintenance treatment.
- Conditions
- Opiate Withdrawal Syndrome
- Being tested
- Ear acupressure alone, Electroacupuncture plus ear acupressure
- Keywords
- methadone, heroin, acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear acupressure aloneProcedure or surgery
Also called Auricular acupressure
The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes then were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
Electroacupuncture plus ear acupressureProcedure or surgery
Also called Electric acupuncture
Acupuncture included Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation was conducted. The frequency of electrical stimulation was 5 Hz and wave form was adjustable. The intensities of the stimulation were increased in 1 mA increments to maximal tolerable intensity. At the same time, The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes. After 15 minutes treatment, acupuncture needles were removed and magnet pellets were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ear acupressure & Electroacupuncture (A) | Experimental | Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe. Receives: Procedure: Ear acupressure alone; Procedure: Electroacupuncture plus ear acupressure |
| Ear acupressure & Electroacupuncture (B) | Experimental | Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe. Receives: Procedure: Ear acupressure alone; Procedure: Electroacupuncture plus ear acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessed the change of opioid craving
opioid craving scores on the Visual Analog Scale
Measured: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Secondary outcomes (4)
Assessed the change of life quality
Life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)
Measured: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Assessed the change of emotion problem
Emotion problems was evaluated by Beck anxiety and Depression inventory
Measured: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Opiate usage
Use urine test to detect opiate use
Measured: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Assessed the change of sleep quality
Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
Measured: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJun 2016
- Primary completion30 Mar 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opiate Withdrawal SyndromeStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu-Tung Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Chen Ouyang, Lu-Tung Christian Hospital
- Investigators
- Wen-Chen Ouyang, Ph.D., Principal investigator, Lu-Tung Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012373
- Sponsor's protocol ID
- LuTungCH-1
- Acronym
- AAMTH
- Status last verified
- Dec 2017
- First submitted
- 29 Oct 2016
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chan YY, Lo WY, Li TC, Shen LJ, Yang SN, Chen YH, Lin JG. Clinical efficacy of acupuncture as an adjunct to methadone treatment services for heroin addicts: a randomized controlled trial. Am J Chin Med. 2014;42(3):569-86. doi: 10.1142/S0192415X14500372.
PubMed 24871652Lin JG, Chan YY, Chen YH. Acupuncture for the treatment of opiate addiction. Evid Based Complement Alternat Med. 2012;2012:739045. doi: 10.1155/2012/739045. Epub 2012 Feb 22.
PubMed 22474521Boyuan Z, Yang C, Ke C, Xueyong S, Sheng L. Efficacy of acupuncture for psychological symptoms associated with opioid addiction: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:313549. doi: 10.1155/2014/313549. Epub 2014 Nov 4.
PubMed 25530779
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
- ClinicalTrials.gov ID
- NCT03012373
- Acronym / sponsor ID
- AAMTH / LuTungCH-1
- Conditions
- Opiate Withdrawal Syndrome
- Keywords
- methadone, heroin, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lu-Tung Christian HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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 is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy both combined with methadone treatment services for heroin addicts.
Detailed description
Methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on Methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years. Therefore, adjuvant therapeutic interventions for heroin addiction patients are needed. Since 1996, the World Health Organization (WHO) has classified acupuncture treatment indications, including drug abuse. The purpose of this study is to compare the difference of efficacy between ear acupressure alone and ear acupressure plus electrical acupuncture therapy both combined with standard methadone maintenance therapy to the heroin addicts.
Patients who receive methadone were randomly assigned to sequence A and B. Sequence A(n=20) receive ear Acupressure combined with electroacupuncture for four weeks, followed by one week wash-out period. Then ear acupressure alone for another four weeks.
Sequence B(n=20) receive EAR acupressure alone for four weeks first, and followed by one week wash-out period, then ear acupressure combined with electroacupuncture for another four weeks. Measures of methadone dosage and using the craving visual analog scale (VAS) to assess the craving severity for 8 weeks. Using the Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) to assess improvement of life quality and sleep quality. Using Beck anxiety and Depression inventory to evaluate emotional problems. Urine opiate screenings are provided after 4 weeks , 8 weeks treatment and 1 month after end of treatment, to screen opiate reuse.
The study hypothesis was acupuncture had more clinical efficacy than ear acupressure upon craving severity, life quality, mood stability ,reduced methadone dosage and sleep quality when provided as an adjunct to a standard methadone maintenance treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ear acupressure & Electroacupuncture (A) | Experimental | Procedure: Ear acupressure alone, Procedure: Electroacupuncture plus ear acupressureElectroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe. |
| Ear acupressure & Electroacupuncture (B) | Experimental | Procedure: Ear acupressure alone, Procedure: Electroacupuncture plus ear acupressureElectroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for Opioid Use Disorder and had been received methadone maintenance treatment for more then one month.
Key exclusion criteria (8 listed)
- had taking acupuncture treatment in past 30 days
- had severe adverse effects or events history from receiving acupuncture treatment
- had any serious physical illness
- had a significant risk of suicide
- ear infection
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 |
|---|---|---|
| Ear acupressure aloneAlso: Auricular acupressureThe magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes then were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks. | Procedure or surgery | Ear acupressure & Electroacupuncture (A), Ear acupressure & Electroacupuncture (B) |
| Electroacupuncture plus ear acupressureAlso: Electric acupunctureAcupuncture included Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation was conducted. The frequency of electrical stimulation was 5 Hz and wave form was adjustable. The intensities of the stimulation were increased in 1 mA increments to maximal tolerable intensity. At the same time, The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes. After 15 minutes treatment, acupuncture needles were removed and magnet pellets were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks. | Procedure or surgery | Ear acupressure & Electroacupuncture (A), Ear acupressure & Electroacupuncture (B) |
Primary outcome
Assessed the change of opioid craving
Time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
opioid craving scores on the Visual Analog Scale
4 secondary outcomes
Assessed the change of life quality
Time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Assessed the change of emotion problem
Time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Opiate usage
Time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Assessed the change of sleep quality
Time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Background: PubMed 24871652Chan YY, Lo WY, Li TC, Shen LJ, Yang SN, Chen YH, Lin JG. Clinical efficacy of acupuncture as an adjunct to methadone treatment services for heroin addicts: a randomized controlled trial. Am J Chin Med. 2014;42(3):569-86. doi: 10.1142/S0192415X14500372.
- Background: PubMed 22474521Lin JG, Chan YY, Chen YH. Acupuncture for the treatment of opiate addiction. Evid Based Complement Alternat Med. 2012;2012:739045. doi: 10.1155/2012/739045. Epub 2012 Feb 22.
- Background: PubMed 25530779Boyuan Z, Yang C, Ke C, Xueyong S, Sheng L. Efficacy of acupuncture for psychological symptoms associated with opioid addiction: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:313549. doi: 10.1155/2014/313549. Epub 2014 Nov 4.
- Individual participant dataSharing planned: Undecided
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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-Chen Ouyang, Ph.D. principal investigator
Lu-Tung Christian 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 Ear acupressure alone and Electroacupuncture plus ear acupressure in people with Opiate Withdrawal Syndrome, run by Lu-Tung Christian 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 8 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 5 Dec 2017. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessed the change of opioid craving (time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03012373, which also lists 3 linked publications.
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 5 Dec 2017.