NCT03969251

Brief Summary

This is a pilot study designed to evaluate the efficacy of High Frequency (HF) repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L-DLPFC) at improving cognitive flexibility in recently detoxified individuals with alcohol use disorder (AUD) compared to placebo (Sham rTMS). The total number of subjects requested to be randomized is 20. The investigator will need to screen about 40 subjects to have 20 subjects started on rTMS session at a ratio of 2 screens/1 subject randomized.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

March 27, 2019

Last Update Submit

October 25, 2020

Conditions

Alcoholism

Keywords

alcoholalcohol dependenceaddictionalcohol use disorder

Outcome Measures

Primary Outcomes (4)

  • Wisconsin Card Sorting Test (WCST)

    This is a neuropsychological task that measures flexibility in thinking, or "set shifting," during changing reinforcement schedules.

    Up to 5 months

  • Dimensional Change Card Sort Task (DCCST)

    This is a neuropsychological task that measures cognitive flexibility and attention.

    Up to 5 months

  • Flanker Inhibitory Control and Attention Test (FICAT)

    This is a neuropsychological task that measures attention and inhibitory control.

    Up to 5 months

  • List Sorting Working Memory Test (LSWMT)

    This is a neuropsychological task that measures working memory.

    Up to 5 months

Secondary Outcomes (4)

  • Drinks Per Drinking Day

    Up to 5 months

  • Percentage of Days of Abstinence

    Up to 5 months

  • Percentage of Heavy Drinking Days

    Up to 5 months

  • Alcohol Craving Questionnaire (ACQ-NOW)

    Up to 5 months

Study Arms (2)

Transcranial Magnetic Stimulation (rTMS)

EXPERIMENTAL

repetitive transcranial magnetic stimulation

Device: Transcranial Magnetic Stimulation (rTMS)

Sham (SS)

SHAM COMPARATOR

repetitive sham rTMS

Device: Sham (SS)

Interventions

Transcranial Magnetic Stimulation (rTMS)DEVICE

active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex

Transcranial Magnetic Stimulation (rTMS)
Sham (SS)DEVICE

repetitive sham rTMS

Sham (SS)

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right handed males and females who have given written informed consent.
  • 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.

You may not qualify if:

  • Please contact site for additional information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UVA Center for Leading Edge Addiction Research

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

AlcoholismBehavior, Addictive

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Nassima Ait-Daoud TIouririne, M.D.

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Jenkins-Mendoza

CONTACT

(434)243-0562emj9c@virginia.edu

Tracie Kostelac

CONTACT

(434)243-0563tlk5d@virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Director of UVA Center for Leading Edge Addiction Research

Study Record Dates

First Submitted

March 27, 2019

First Posted

May 31, 2019

Study Start

July 1, 2019

Primary Completion

March 1, 2021

Study Completion

June 1, 2021

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)