Status:
COMPLETED
Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder
Lead Sponsor:
The Mind Research Network
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ou...
Detailed Description
To achieve study aims, 34 treatment seeking adults with AUD will be recruited from local intensive outpatient (IOP) treatment programs and randomized to treatment with either inhibitory 1Hz rTMS to ce...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03829761
Start Date
February 20 2019
End Date
September 7 2023
Last Update
October 23 2023
Active Locations (1)
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1
The Mind Research Network
Albuquerque, New Mexico, United States, 87106