Benzodiazepine DependenceNCT02475538
Electroacupuncture for Tapering Off Long-term Benzodiazepine Use
A study testing Electroacupuncture in people with Benzodiazepine Dependence, run by The University of Hong Kong at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Benzodiazepine Dependence
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 3 sitesChina
- Study dates
- Jul 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Department of Psychiatry, Kowloon Hospital
Hong Kong
Man-Kin Roger Ng
- Recruiting
Department of Psychiatry, Queen Mary Hospital
Hong Kong
Ka-Fai Chung
- Recruiting
Department of Psychiatry, United Christian Hospital
Hong Kong
Lai-wah Connie Chan
About this study
Official title: Electroacupuncture for Tapering Off Long-term Benzodiazepine Use: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Benzodiazepine Dependence
- Being tested
- Electroacupuncture, Placebo acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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 acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who successfully discontinued benzodiazepines
Measured: up to 12-week post-treatment
Secondary outcomes (4)
The percentage of equivalent dose of benzodiazepines reduced
Different type of benzodiazepines are tranformed into an equivalent dose of diazepam
Measured: 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)
20-item, self-administered withdrawal symptom questionnaire
Measured: 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)
7-item 5-point Likert self-rating scale on the severity of insomnia and the distress
Measured: 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)
14-item self-administrated questionnaire, which will be used to assess the severity of depressive and anxiety symptoms
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benzodiazepine DependenceStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. YEUNG Wing-Fai, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475538
- Sponsor's protocol ID
- AcupBen
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2015
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30504097Yeung 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.
PubMed 28359309
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Tapering Off Long-term Benzodiazepine Use: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02475538
- Acronym / sponsor ID
- AcupBen
- Conditions
- Benzodiazepine Dependence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Device: ElectroacupunctureSubjects 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 comparator | Device: Placebo acupunctureSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureGradual 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. | Device | Electroacupuncture |
| Placebo acupunctureGradual 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. | Device | Placebo acupuncture |
Primary outcome
The proportion of participants who successfully discontinued benzodiazepines
Time frame: up to 12-week post-treatment
4 secondary outcomes
The percentage of equivalent dose of benzodiazepines reduced
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Derived from this study: PubMed 30504097Yeung 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.
- Derived from this study: PubMed 28359309Yeung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Benzodiazepine Dependence, run by The University of Hong Kong at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yee-Man Branda (+852 9727 7742, branda.ym.yu@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants who successfully discontinued benzodiazepines (time frame: up to 12-week post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475538, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.