NCT02691390

Brief Summary

dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for at least 5 days.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_1

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

3.5 years

First QC Date

February 7, 2016

Last Update Submit

December 27, 2020

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

  • Alcohol usage

    The percentage of heavy drinking days (pHDD; 4+ alcohol units per women and 5+ for men, within one day) between the active and sham groups over the follow up period.

    12 weeks post treatment

Secondary Outcomes (1)

  • Alcohol craving

    12 weeks post treatment

Other Outcomes (3)

  • Modifications to brain volume

    3 weeks of treatment

  • Modifications to functional connectivity

    3 weeks of treatment

  • Modifications to blood-oxygen-level-dependent (BOLD) signal

    3 weeks of treatment

Study Arms (2)

study group

EXPERIMENTAL

alcoholics - dTMS group

Device: Active dTMS

control group

SHAM COMPARATOR

alcoholics - sham group

Device: Sham dTMS

Interventions

Active dTMSDEVICE

dTMS to ACC

study group
Sham dTMSDEVICE

SHAM - no stimulation

control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 65
  • Current diagnosis of alcohol dependence
  • Alcohol use in the past month
  • Right handed (self-report)
  • If female, negative urine pregnancy test
  • If female, must either agree to practice an effective birth control method; agree to abstinence from intercourse; be surgically sterile or postmenopausal for at least one year

You may not qualify if:

  • Currently pregnant or breastfeeding
  • More than mild cognitive impairment, as determined by a score on the Montreal cognitive assessment (MoCA) \<25.
  • Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder
  • Use in the past 2 weeks of medication or illicit drug with known high pro-convulsant action, as self-reported, or detected using urine toxicology screening; and with accordance to the Physician best Judgment.
  • Any history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for \> 5 minutes and retrograde amnesia for \> 30 minutes (self-reported history).
  • Any history of seizures other than febrile childhood seizures (self-reported history)
  • Clinically significant hearing impairment
  • Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant. Some of the patients that will be excluded from the imaging part of the study will be included in the clinical part.
  • Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the investigators and after any consults if indicated, participation in the study is not in the best interest of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of neuropsychiatric clinic soroka medical center

Study Record Dates

First Submitted

February 7, 2016

First Posted

February 25, 2016

Study Start

July 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 1, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share