Electroacupuncture for Tapering Off Long-term Benzodiazepine Use
- Conditions
- Benzodiazepine Dependence
- Interventions
- Device: ElectroacupunctureDevice: Placebo acupuncture
- Registration Number
- NCT02475538
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
This study aims to examine the efficacy of electroacupuncture for tapering benzodiazepines in long-term users. All eligible subjects will be randomized in a ratio of 1:1 to (1) Electroacupuncture combined with gradual tapering; and (2) Placebo acupuncture combined with gradual tapering.
- Detailed Description
Recent randomized controlled studies support that acupuncture has beneficial effects for insomnia. Primary insomnia patients receiving electroacupuncture showed an increase in sleep diary-derived sleep efficiency from an average of 69.8% at baseline to 81.2% at 1-week post-treatment. A similar result was found in patients with residual insomnia associated with major depressive disorder.
Acupuncture is efficacious in alleviating anxiety and insomnia symptoms; hence, it may help to reduce the impacts of withdrawal symptoms during benzodiazepine tapering. However, there has been no randomized controlled trial to examine the efficacy and safety of acupuncture on benzodiazepine discontinuation.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 144
- aged ≥ 18 years
- taking benzodiazepines (World Health Organization Anatomical, Therapeutic and Chemical classification system codes N05BA, N05CD, N05CF, and M03BX07)) on more than 50% of days for at least 3 months and during their prospective 2-week record prior to baseline
- willing to withdraw their benzodiazepine use during the study,
- any relapse of psychiatric disorder in the past year that required intervention,
- Hospital Anxiety and Depression Scale depression or anxiety as a tool (subscore ≥ 8) which indicates subjects with possible depression or anxiety
- have any unstable psychiatric conditions or serious physical illnesses which are judged by the investigator to render unsuitable or unsafe;
- have valvular heart defects or bleeding disorders, taking anticoagulant drugs, or are fitted with any implanted electrical device such as pacemaker, defibrillator, or brain stimulation,
- have received any acupuncture during the previous 6 months prior to baseline,
- are pregnant, breast-feeding or of childbearing potential but not using adequate contraception,
- have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe and
- significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (a score ≥ 3)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electroacupuncture Electroacupuncture Subjects in this group will be treated with electroacupuncture along with a gradual tapering schedule. Benzodiazepines will be tapered off over four weeks. The expected reduction rate of benzodiazepines should be 25% in the first two weeks and 12.5% in 3-4 days in week 3 and week 4. If the participants cannot tolerate the effects after tapering according to our suggested plan, the dose can be kept unchanged or they can reduce the dose at a slower pace. Subjects will receive electroacupuncture 2 times per week for 4 consecutive weeks. Electroacupuncture involves acupuncture needling at traditionally used acupoints according to Chinese medicine theory. Placebo acupuncture Placebo acupuncture Subjects in this group will be treated with placebo acupuncture along with a gradual tapering schedule. Benzodiazepines will be tapered off over four weeks. The expected reduction rate of benzodiazepines should be 25% in the first two weeks and 12.5% in 3-4 days in week 3 and week 4. If the participants cannot tolerate the effects after tapering according to our suggested plan, the dose can be kept unchanged or they can reduce the dose at a slower pace. The subjects will be receive placebo acupuncture 2 times per week for 4 consecutive weeks. Placebo acupuncture is a treatment that simulates the procedure of acupuncture treatment but may not have the effects of acupuncture.
- Primary Outcome Measures
Name Time Method The proportion of participants who successfully discontinued benzodiazepines up to 12-week post-treatment
- Secondary Outcome Measures
Name Time Method The percentage of equivalent dose of benzodiazepines reduced First week of treatment (week 1), second week of treatment (week 2), third week of treatment (week 3), fourth week of treatment (week 4), 2-week post-treatment (week 6) and 12-week post-treatment (week 16) Different type of benzodiazepines are tranformed into an equivalent dose of diazepam
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) First week of treatment (week 1), second week of treatment (week 2), third week of treatment (week 3), fourth week of treatment (week 4), 2-week post-treatment (week 6) and 12-week post-treatment (week 16) 20-item, self-administered withdrawal symptom questionnaire
Insomnia Severity Index (ISI) second week of treatment (week 2), fourth week of treatment (week 4), 2-week post-treatment (week 6) and 12-week post-treatment (week 16) 7-item 5-point Likert self-rating scale on the severity of insomnia and the distress
Hospital Anxiety and Depression Scale (HADS) second week of treatment (week 2), fourth week of treatment (week 4), 2-week post-treatment (week 6) and 12-week post-treatment (week 16) 14-item self-administrated questionnaire, which will be used to assess the severity of depressive and anxiety symptoms
Trial Locations
- Locations (3)
Department of Psychiatry, Queen Mary Hospital
🇨🇳Hong Kong, China
Department of Psychiatry, Kowloon Hospital
🇨🇳Hong Kong, China
Department of Psychiatry, United Christian Hospital
🇨🇳Hong Kong, China