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Alcohol DependenceTADNCT03910686

Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Alcohol Dependence

A study testing Transcranial magnetic stimulation and cognitive behavioral therapy in people with Alcohol Dependence, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Alcohol dependence is one of most common substance dependence, which brings great burden on health worldwide. Alcohol dependence may lead to many serious diseases or consequences including cancer, cardiovascular diseases and accidents. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Dependence
What is being tested?
Transcranial magnetic stimulation and cognitive behavioral therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteChina
Study dates
30 Jun 2019to Dec 2021
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis as alcohol dependence according to DSM-IV criteria
  • No definite history of neurological diseases and psychological problems
  • Volunteer to participate the study, cooperate to be followed up

Who cannot join

  • Acute withdrawal state and CIWA score > 9
  • With other neurological diseases and psychological problems
  • With ever brain trauma and damage
  • With other psychological medications or other substance dependence
  • With other contraindications to have transcranial magnetic stimulation

Trial locations and contacts

1 site in 1 country.

Ying Peng, MD, PhD contact

+86-13380051581

pengy2@mail.sysu.edu.cn

Hongxuan Wang, MD, PhD contact

+86-13824498978

wanghx8@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Recruiting

Other trials in China

About this study

Alcohol dependence is one of most common substance dependence, which brings great burden on health worldwide. Alcohol dependence may lead to many serious diseases or consequences including cancer, cardiovascular diseases and accidents. Once alcohol dependence is developed, it will be difficult to recover and easy to relapse. Although many efforts had been made in the treatment of alcohol dependence, the annual recurrence of alcohol dependence with traditional therapies was over 45%. Repetitive transcranial magnetic stimulation (rTMS) on the dorsolateral prefrontal cortex (DLPFC) or cognitive behavioral therapy (CBT) each alone was reported to have some effect on preventing from relapse of alcohol dependence. In order to test whether combined therapy of high frequency rTMS (hf-rTMS) with CBT is better for preventing from relapse of alcohol dependence, we recruit patients with alcohol dependence to participate this study. The study is a factorial designed and the patients will be assigned into one of the following six groups randomly: (1) regular treatment (symptomatic treatment) with blank TMS; (2) regular treatment (RT) with blank TMS and CBT; (3) RT with right DLPFC hf-rTMS; (4) RT with right DLPFC hf-rTMS and CBT; (5) RT with left DLPFC hf-rTMS; (6) RT with left DLPFC hf-rTMS and CBT. TMS was given 5 days per week for total 2 weeks using uniform scheme (5 seconds of 10Hz stimulation per train, 30 trains per day with inter-train interval of 20 seconds). CBT will be given once per week for total 8 weeks. The patients will be followed up for 6 months. Recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other cognitive psychological assessments will be recorded and compared among the 6 treatment groups and the efficacy of combined therapy of rTMS with CBT will be evaluated in our study.

Being tested
Transcranial magnetic stimulation and cognitive behavioral therapy
Keywords
Alcohol Dependence, transcranial magnetic stimulation, cognitive behavioral therapy
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial magnetic stimulation and cognitive behavioral therapyCombination product

    Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy

Study groups in NCT03910686
Study groupRoleWhat they receive
Regular treatment (symptomatic treatment) with blank TMSPlacebo comparatorRegular treatment (symptomatic treatment) with blank transcranial magnetic stimulation
Receives: Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
Regular treatment (RT) with blank TMS and CBTActive comparatorRegular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy
Receives: Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
RT with right DLPFC hf-rTMSActive comparatorRegular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Receives: Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
RT with right DLPFC hf-rTMS and CBTActive comparatorRegular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Receives: Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
RT with left DLPFC hf-rTMSActive comparatorRegular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Receives: Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
RT with left DLPFC hf-rTMS and CBTActive comparatorRegular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Receives: Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of relapse of alcohol dependence after discharge from hospital

    Recurrence of alcohol dependence

    Measured: 1 month

  2. The rate of relapse of alcohol dependence after discharge from hospital

    Measured: 2 month

  3. The rate of relapse of alcohol dependence after discharge from hospital

    Measured: 3 month

  4. The rate of relapse of alcohol dependence after discharge from hospital

    Measured: 6 month

Secondary outcomes (8)

  1. Duration of abstinence

    The total time or period without any intake of alcohol during follow ups

    Measured: 6 months

  2. Alcohol intake

    Diaries of alcohol intake in different time of the follow ups

    Measured: 2 weeks, 1 month, 2 months, 3 months and 6 months

  3. Craving for alcohol

    Craving assessment for alcohol by Obsessive Compulsive Drinking Scale (OCDS) ranging from 0 to 40. Higher score of OCDS indicates more desire for alcohol.

    Measured: 2 weeks, 1 month, 2 months, 3 months and 6 months

  4. Craving for alcohol

    Craving assessment by Visual Analogue Scale (VAS) for alcohol desire ranging from 0 to 10. Higher score indicates more desire for alcohol.

    Measured: 2 weeks, 1 month, 2 months, 3 months and 6 months

  5. Cognitive assessment

    Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.

    Measured: 2 weeks, 1 month, 2 months, 3 months and 6 months

  6. Psychological assessment - Anxiety

    Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.

    Measured: 2 weeks, 1 month, 2 months, 3 months and 6 months

  7. Psychological assessment - Depression

    Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.

    Measured: 2 weeks, 1 month, 2 months, 3 months and 6 months

  8. Psychological assessment - Sleep

    Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.

    Measured: 2 weeks, 1 month, 2 months, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2019
  2. Study start30 Jun 2019
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03910686
Sponsor's protocol ID
2019-12-TMSCBT
Acronym
TAD
Status last verified
Mar 2021
First submitted
3 Apr 2019
Last updated
22 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Phillips MR, Zhang J, Shi Q, Song Z, Ding Z, Pang S, Li X, Zhang Y, Wang Z. Prevalence, treatment, and associated disability of mental disorders in four provinces in China during 2001-05: an epidemiological survey. Lancet. 2009 Jun 13;373(9680):2041-53. doi: 10.1016/S0140-6736(09)60660-7.

    PubMed 19524780

  • Tang YL, Hao W, Leggio L. Treatments for alcohol-related disorders in China: a developing story. Alcohol Alcohol. 2012 Sep-Oct;47(5):563-70. doi: 10.1093/alcalc/ags066. Epub 2012 Jun 7.

    PubMed 22683652

  • Mishra BR, Nizamie SH, Das B, Praharaj SK. Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. Addiction. 2010 Jan;105(1):49-55. doi: 10.1111/j.1360-0443.2009.02777.x.

    PubMed 20078462

  • Herremans SC, Vanderhasselt MA, De Raedt R, Baeken C. Reduced intra-individual reaction time variability during a Go-NoGo task in detoxified alcohol-dependent patients after one right-sided dorsolateral prefrontal HF-rTMS session. Alcohol Alcohol. 2013 Sep-Oct;48(5):552-7. doi: 10.1093/alcalc/agt054. Epub 2013 May 24.

    PubMed 23709633

  • Mishra BR, Praharaj SK, Katshu MZ, Sarkar S, Nizamie SH. Comparison of anticraving efficacy of right and left repetitive transcranial magnetic stimulation in alcohol dependence: a randomized double-blind study. J Neuropsychiatry Clin Neurosci. 2015 Winter;27(1):e54-9. doi: 10.1176/appi.neuropsych.13010013.

    PubMed 25255169

  • Herremans SC, De Raedt R, Van Schuerbeek P, Marinazzo D, Matthys F, De Mey J, Baeken C. Accelerated HF-rTMS Protocol has a Rate-Dependent Effect on dACC Activation in Alcohol-Dependent Patients: An Open-Label Feasibility Study. Alcohol Clin Exp Res. 2016 Jan;40(1):196-205. doi: 10.1111/acer.12937.

    PubMed 26727534

  • Sundstrom C, Kraepelien M, Eek N, Fahlke C, Kaldo V, Berman AH. High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorder: a pilot study. BMC Psychiatry. 2017 May 26;17(1):197. doi: 10.1186/s12888-017-1355-6.

    PubMed 28549424

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial magnetic stimulation and cognitive behavioral therapy in people with Alcohol Dependence, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site 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 5 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 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Ying Peng, MD, PhD (+86-13380051581, pengy2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of relapse of alcohol dependence after discharge from hospital (time frame: 1 month). The study lists 4 primary outcomes in all. 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 NCT03910686, which also lists 7 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 22 Mar 2021.

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