Electroacupuncture for Tapering Off Long-term Benzodiazepine Use

NCT02475538 | Unknown

• 1 other identifier: AcupBen
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

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.

Conditions

Benzodiazepine Dependence

Outcome Measures

Primary Outcomes (1)

• The proportion of participants who successfully discontinued benzodiazepines

  up to 12-week post-treatment

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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.

Device: Electroacupuncture

Placebo acupuncture

PLACEBO COMPARATOR

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.

Device: Placebo acupuncture

Interventions

Electroacupuncture DEVICE

Gradual Tapering Benzodiazepines will be tapered off over four weeks. The subjects will be told by a blinded researcher to reduce their daily dose by 25% in the 1st and 2nd week. For the remaining 50%, subjects will be asked to reduce the dose by 12.5% each time for 3-4 days in the 3rd and 4th week. Subjects who are unable to taper according to the suggested plan can reduce dose at a slower pace. Electroacupuncture The subjects will be treated with electroacupuncture at bilateral Sishencong (EX-HN1), Anmian, Shuaigu (GB8), Touwei (ST8), Taiyang (EX-HN5), Toulinqi (GB15), Neiguan (PC6), Shenmen (HT7), Sanyinjiao (SP6), Taichong (LV3), and unilateral Yintang (EX-HN3), Shenting (GV24), and Baihui (GV20). "De qi" is achieved if possible. The intensity of electric-stimulation will be adjusted up to a level the subject can tolerate without undue discomfort. The needles will be left for 30 min.

Electroacupuncture

Placebo acupuncture DEVICE

Gradual Tapering The gradual tapering procedure will be the same as in the "Electroacupuncture combined with gradual tapering" group. Placebo acupuncture Placebo needles designed by Streitberger will be used. The placebo needles are inserted to the site 1 inch beside the acupoints of the electroacupuncture group in order to avoid acupressure effect. The needles are held by surgical tape or hair pin to imitate the procedure of acupuncture. The needles are connected to an electric-stimulator with zero frequency and amplitude. The number, duration and frequency of treatment session will be the same as in the "Electroacupuncture combined with gradual tapering" group.

Placebo acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,
• significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (a score ≥ 3)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (3)

Department of Psychiatry, Kowloon Hospital

Hong Kong, China

RECRUITING

Department of Psychiatry, Queen Mary Hospital

Hong Kong, China

RECRUITING

Department of Psychiatry, United Christian Hospital

Hong Kong, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 30504097 DERIVED

• 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.

  PMID: 28359309 DERIVED

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Yee-Man Branda

CONTACT

+852 9727 7742; branda.ym.yu@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 18, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

CN (3)