Opiate Withdrawal Syndrome
Conditions
Keywords
methadone, heroin, acupuncture
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.
Interventions
PROCEDUREEar 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.
PROCEDUREElectroacupuncture 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.
Sponsors
Lu-Tung Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessed the change of opioid craving | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessed the change of life quality | Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment | Life quality was assessed using the Taiwanese version of Short Form 36 (SF-36) |
| Assessed the change of emotion problem | Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment | Emotion problems was evaluated by Beck anxiety and Depression inventory |
| Opiate usage | Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment | Use urine test to detect opiate use |
| Assessed the change of sleep quality | Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment | Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) |
Countries
Taiwan
Outcome results
None listed