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

Lu-Tung Christian Hospital

Status: Unknown

Conditions: Opiate Withdrawal Syndrome

Treatments: Procedure: Electroacupuncture plus ear acupressure; Procedure: Ear acupressure alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03012373

LuTungCH-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ear acupressure & Electroacupuncture (A)

Experimental group

Description:

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.

Treatment:

Procedure: Ear acupressure alone

Procedure: Electroacupuncture plus ear acupressure

Ear acupressure & Electroacupuncture (B)

Experimental group

Description:

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.

Treatment:

Procedure: Ear acupressure alone

Procedure: Electroacupuncture plus ear acupressure