Electroacupuncture for Tapering Off Long-term Benzodiazepine Use

Benzodiazepine Dependence Clinical Trial

Official title:

Electroacupuncture for Tapering Off Long-term Benzodiazepine Use: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02475538
• Other study ID #: AcupBen
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2015
• Last updated: June 13, 2017
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: The University of Hong Kong
• Contact: Yee-Man Branda
• Phone: +852 9727 7742
• Email: branda.ym.yu[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benzodiazepine Dependence

Intervention

Device:
• Electroacupuncture
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.
• Placebo acupuncture
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.

Locations

Country	Name	City	State
China	Department of Psychiatry, Kowloon Hospital	Hong Kong
China	Department of Psychiatry, Queen Mary Hospital	Hong Kong
China	Department of Psychiatry, United Christian Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of participants who successfully discontinued benzodiazepines		up to 12-week post-treatment
Secondary	The percentage of equivalent dose of benzodiazepines reduced	Different type of benzodiazepines are tranformed into an equivalent dose of diazepam	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)
Secondary	Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)	20-item, self-administered withdrawal symptom questionnaire	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)
Secondary	Insomnia Severity Index (ISI)	7-item 5-point Likert self-rating scale on the severity of insomnia and the distress	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)
Secondary	Hospital Anxiety and Depression Scale (HADS)	14-item self-administrated questionnaire, which will be used to assess the severity of depressive and anxiety symptoms	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)