Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts

Opiate Withdrawal Syndrome Clinical Trial

— AAMTH  

Official title:

Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03012373
• Other study ID #: LuTungCH-1
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 29, 2016
• Last updated: December 4, 2017
• Start date: June 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: December 2017
• Source: Lu-Tung Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: May 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

1. had taking acupuncture treatment in past 30 days

2. had severe adverse effects or events history from receiving acupuncture treatment

3. had any serious physical illness

4. had a significant risk of suicide

5. ear infection

6. were pregnant or or a woman plan to pregnant

7. had bleeding disorders or were taking anticoagulant drugs

8. had epilepsy, cerebral vascular disease and brain injured history.

Related Conditions & MeSH terms

• Opiate Withdrawal Syndrome
• Substance Withdrawal Syndrome

Intervention

Procedure:
• Ear acupressure alone
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 acupressure
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.

Locations

Country	Name	City	State
Taiwan	Lu-Tung Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Lu-Tung Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Boyuan 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. Review. — View Citation

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. — View Citation

Lin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessed the change of opioid craving	opioid craving scores on the Visual Analog Scale	Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Secondary	Assessed the change of life quality	Life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)	Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Secondary	Assessed the change of emotion problem	Emotion problems was evaluated by Beck anxiety and Depression inventory	Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Secondary	Opiate usage	Use urine test to detect opiate use	Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Secondary	Assessed the change of sleep quality	Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)	Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment

External Links

•   Detoxification and Substance Abuse Treatment.
•   WHO traditional medicine strategy