Clinical trial NCT02475538: Electroacupuncture for Tapering Off Long-term Benzodiazepine Use
Official title: Electroacupuncture for Tapering Off Long-term Benzodiazepine Use: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benzodiazepine Dependence
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The proportion of participants who successfully discontinued benzodiazepines
timeFrame: up to 12-week post-treatment
Secondary outcomes:
measure: The percentage of equivalent dose of benzodiazepines reduced
timeFrame: 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)
measure: Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)
timeFrame: 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)
measure: Insomnia Severity Index (ISI)
timeFrame: 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)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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)
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Psychiatry, Kowloon Hospital
city: Hong Kong
country: China
facility: Department of Psychiatry, Queen Mary Hospital
city: Hong Kong
country: China
facility: Department of Psychiatry, United Christian Hospital
Study officials:
References:
citation: Yeung WF, Chung KF, Zhang ZJ, Zhang SP, Chan WC, Ng RM, Chan CL, Ho LM, Yu BY, Chau JC, Lau NC, Lao LX. Electroacupuncture for tapering off long-term benzodiazepine use: A randomized controlled trial. J Psychiatr Res. 2019 Feb;109:59-67. doi: 10.1016/j.jpsychires.2018.11.015. Epub 2018 Nov 22.
citation: Yeung WF, Chung KF, Zhang ZJ, Chan WC, Zhang SP, Ng RM, Chan CL, Ho LM, Yu YM, Lao LX. Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial. BMC Complement Altern Med. 2017 Mar 31;17(1):183. doi: 10.1186/s12906-017-1692-5.