Clinical trial NCT03829761: Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder
Official title: Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for Reduction of Negative Affect and Treatment of Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: rTMS
Lead sponsor: The Mind Research Network
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-02-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 cerebellar vermis given daily for 2 weeks (total of 10 sessions) or sham. Alcohol use outcomes, self-reported negative affect, and craving will be obtained at baseline, 1 day, 1 week and 6 weeks following rTMS termination. An fMRI scan during a Stroop task will be obtained at baseline and 1 day after the final rTMS session.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Time to drinking relapse as measured by the Time Line Follow Back
timeFrame: 8 weeks
measure: Change in percent days abstinent as measured by the Time Line Follow Back
timeFrame: 3 weeks
measure: Change in self reported negative affect as measured by the Promise anger, anxiety and depression scales
timeFrame: 2 weeks
measure: 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
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: The Mind Research Network
state: New Mexico
Study officials:
affiliation: The Mind Research Network
name: Jon M Houck, PhD
role: PRINCIPAL_INVESTIGATOR
References: