Clinical trial NCT03012373: Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
Official title: Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opiate Withdrawal Syndrome
Keywords: methadone
heroin
acupuncture
Lead sponsor: Lu-Tung Christian Hospital
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessed the change of opioid craving
timeFrame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Secondary outcomes:
measure: Assessed the change of life quality
timeFrame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
measure: Assessed the change of emotion problem
timeFrame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
measure: Opiate usage
timeFrame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
measure: Assessed the change of sleep quality
timeFrame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Lu-Tung Christian Hospital
Study officials:
affiliation: Lu-Tung Christian Hospital
name: Wen-Chen Ouyang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.