Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder
NCT ID: NCT03969251
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-07-01
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
To test the hypothesis, the investigator propose a 2 phase design:
Phase 1: 6-week trial comparing the efficacy of active high-frequency (HF) rTMS of L-DLPFC versus sham (SS) rTMS to determine if HF rTMS improves cognitive flexibility in recently detoxified alcoholics Phase 2: at the end of TMS phase, all participants will receive cognitive behavioral therapy (CBT) thus permitting participants with AUD to benefit from cognitive restructuring in CBT, and reduce alcohol cravings and drinking outcomes.
This study will recruit 20 individuals with AUD, comprising of both male and female participants, age 22 years and older interested in alcohol drinking abstinence. Participants will be recruited from the inpatient unit upon discharge after receiving a detoxification treatment and therefore will be abstinent at study entry. Prior to treatment onset and weekly throughout the course of treatment, participants will complete cognitive testing/measures, Wisconsin Card Sorting Task (WCST), Dimensional Change Card Sort Task (DCCST), Barratt Impulsiveness Scale (BIS), Flanker Inhibitory Control and Attention Test (FICAT), and List Sorting Working Memory Test (LSWMT) and self-reported craving measures, Alcohol Craving Questionnaire (ACQ-Now), and Obsessive Compulsive Drinking Scale (OCDS). The drinking timeline follow-back, and adverse events will also be assessed weekly for 8 weeks.
Participant will be randomized to either high frequency (HF) or sham repetitive transcranial magnetic stimulation (SS rTMS), which will be done 5 days per week for 6 weeks. At the end of 6 weeks, all participants will receive weekly CBT for a total of 8 weeks. Participants will return at 2 and 4 weeks for follow-up assessments.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Transcranial Magnetic Stimulation (rTMS)
repetitive transcranial magnetic stimulation
Transcranial Magnetic Stimulation (rTMS)
active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex
Sham (SS)
repetitive sham rTMS
Sham (SS)
repetitive sham rTMS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transcranial Magnetic Stimulation (rTMS)
active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex
Sham (SS)
repetitive sham rTMS
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 22 years and above with a history of alcohol use disorder
* Good physical health
* Have a current diagnosis of alcohol use disorder
* Reports at least 4 "heavy drinking days" on average in the past 30 days.
* Have a BAC by breathalyzer equal to 0.000 when the participants signed the informed consent document
* Six months stability on any psychotropic medications
* Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
* Be able to provide written informed consent, able to understand written and oral instructions in English and be able to complete the questionnaires required by the protocol.
Exclusion Criteria
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nassima Ait-Daoud Tiouririne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nassima Ait-Daoud Tiouririne
Associate Professor, Director of UVA Center for Leading Edge Addiction Research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nassima Ait-Daoud TIouririne, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UVA Center for Leading Edge Addiction Research
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21193
Identifier Type: -
Identifier Source: org_study_id