Abstract
BackgroundOpioid dependence is an increasing public health problem all over the world. Patients with opioid dependence have to receive methadone maintenance therapy (MMT) as replacement therapy for years or even for their entire life. Acupuncture as a kind of therapy has been used to treat substance dependence for many years. Jin’s three-needle acupuncture (JTN), a type of acupuncture technique, has been applied to treat various diseases for several decades. However, JTN as an acupuncture technique has not been used to treat patients receiving MMT. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT.Methods/designThis study is a parallel-arm, randomized controlled trial that aims to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. A total of 140 eligible participants who range in age from 18 to 60 years and fulfil the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), for opiate dependence will be enrolled into this study. All eligible participants will be randomly assigned to the acupuncture group or routine group in a 1:1 allocation ratio. Participants who are enrolled in the acupuncture group will receive MMT and JTN treatment for 30 min per session. Meanwhile, those who are assigned to the routine arm will receive MMT only. All 18 sessions of JTN treatment will be delivered over 6 weeks (3 per week) and followed by a 4-week follow-up period. The primary outcome measure will be the visual analogue scale (VAS) for drug craving and the daily consumption of methadone (DCOM). Secondary outcome measures will include the urine test for opioid use, the 36-item Short Form Survey (SF-36), the Beck Anxiety Inventory (BAI), the Beck Depression Inventory II (BDI-II) and Pittsburgh sleep quality index (PSQI). VAS, DCOM, BAI, BDI-II and the urine test for opioid use will be evaluated at baseline, the second week, the fourth week, the sixth week and the tenth week. SF-36 and PSQI will be assessed at baseline, the fourth week, the sixth week and the tenth week.DiscussionThe results of this trial will provide evidence on the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT.Trial registrationChinese Clinical Trial Registry ChiCTR1900026357. Registered on 2 October 2019.
Highlights
Opioid dependence is an increasing public health problem all over the world
According to the World Drug Report 2018, approximately 31 million people are affected by opioid use disorders through the world, which cause the greatest burden of severe disease and drug-related deaths worldwide [1]
It is an unadaptable state associated with withdrawal symptoms and severe craving, which may lead to the high risk of relapse
Summary
Patients with opioid dependence have to receive methadone maintenance therapy (MMT) as replacement therapy for years or even for their entire life. Withdrawal symptoms mainly include sweating, shaking and diarrhoea in the first few days, accompanied by dysphoria, depression, anxiety and insomnia, which may continue for several months [3, 4]. It is an unadaptable state associated with withdrawal symptoms and severe craving, which may lead to the high risk of relapse. Patients with opioid dependence have to receive MMT as replacement therapy for years or even their entire life. It is necessary to seek a new treatment with efficacy and safety for patients receiving MMT
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