Electroacupuncture for Tapering Off Long-term Benzodiazepine Use

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Benzodiazepine Dependence

Treatments: Device: Electroacupuncture; Device: Placebo acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02475538

AcupBen

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups, including a placebo group

Electroacupuncture

Experimental group

Description:

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.

Treatment:

Device: Electroacupuncture

Placebo acupuncture

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo acupuncture