NCT03829761

Brief Summary

The objective of the current study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on self-reported negative affect, cerebellar brain activation and alcohol use outcomes in alcohol use disorder (AUD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

November 7, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

4.5 years

First QC Date

November 7, 2018

Last Update Submit

October 19, 2023

Conditions

Alcohol Use Disorder

Keywords

rTMS

Outcome Measures

Primary Outcomes (4)

  • Time to drinking relapse as measured by the Time Line Follow Back

    Time to drinking relapse as measured by the Time Line Follow Back from baseline in days.

    8 weeks

  • Change in percent days abstinent as measured by the Time Line Follow Back

    Change in percent days abstinent as measured by the Time Line Follow Back from the 90 days prior to day 1 to day 14-21 (post-treatment).

    3 weeks

  • Change in self reported negative affect as measured by the Promise anger, anxiety and depression scales

    Change in self reported negative affect as measured by the Promise anger, anxiety and depression scale T scores from baseline to day 15 (post-treatment).

    2 weeks

  • Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI

    Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI from baseline to day 15 (post-treatment). This will be calculated using a mask derived from preliminary data from a sample of 33 individuals with AUD at a single timepoint. Activation in this brain region was correlated with depression, anxiety, and recent drinking. Manuscript describing this result is under review (Wilcox et al.), and another manuscript describes the task in question (Wilcox et al. 2014 Cognitive Control Network Function in Alcohol Use Disorder Before and During Treatment With Lorazepam. Subst Use Misuse.

    2 weeks

Study Arms (2)

Cerebellar rTMS

EXPERIMENTAL

Cerebellar rTMS. 1Hz repetitive transcranial magnetic stimulation (rTMS) to cerebellar vermis.

Device: Repetitive transcranial magnetic stimulation (rTMS)

Sham TMS

SHAM COMPARATOR

Sham TMS. Sham transcranial magnetic stimulation to cerebellar vermis.

Device: Sham transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation (rTMS)DEVICE

Repetitive transcranial magnetic stimulation (rTMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of 1Hz stimulation, for a total of 1800 pulses delivered.

Cerebellar rTMS
Sham transcranial magnetic stimulationDEVICE

Sham transcranial magnetic stimulation (TMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of sham stimulation. Sham stimulation will imitate the active rTMS but does not have active stimulation.

Sham TMS

Eligibility Criteria

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

You may qualify if:

  • Males and females age 18-65 meeting DSM-V criteria for moderate or severe AUD in the past year;
  • Interested in cutting down or quitting drinking;
  • Able to provide voluntary informed consent;
  • Have at least 4 heavy drinking days (≥ 5 drinks per day for men, and ≥4 for women) in the past 60 days;
  • Currently receiving treatment for alcohol use disorder.

You may not qualify if:

  • Severe neurological conditions (TBI/stroke/history of a seizure/dementia and other significant cognitive illnesses);
  • Other urgent medical problems, as determined by the study physician from the history and physical exam;
  • Schizophrenia, schizoaffective disorder, bipolar I disorder
  • Suicidal thoughts (intent or plan) in the last month;
  • Current moderate or severe other SUD (except nicotine or marijuana) or other drug (except nicotine or marijuana) use in the past month;
  • Active legal problems with the potential to result in incarceration;
  • Pregnancy or lactation, or child bearing age and sexually active but not on birth control (barrier methods allowed);
  • Current daily use of anti-craving medications, antidepressants (at doses considered therapeutic for depression), benzodiazepines, antipsychotics (at doses considered therapeutic for psychosis or mood stabilization), mood stabilizers (at doses considered therapeutic for mood stabilization);
  • Have previously undergone rTMS (to assure the blind is effective);
  • Personal or familial (in first degree relatives) history of epilepsy;
  • Any contraindication for Magnetic Resonance Imaging (MRI) or TMS including metal shards or certain implants (pacemakers etc.) in the body.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Jon M Houck, PhD

    The Mind Research Network

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Translational Neuroscience

Study Record Dates

First Submitted

November 7, 2018

First Posted

February 4, 2019

Study Start

February 20, 2019

Primary Completion

September 7, 2023

Study Completion

September 7, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)