Active — Not RecruitingPhase 2

Pilot rTMS for AUD+mTBI

United States1 participantsStarted 2019-03-21

Plain-language summary

This is a pilot randomized controlled trial (RCT) for Veteran participants with alcohol use disorder co-occurring with mild traumatic brain injury and/or post-traumatic stress disorder. The treatment intervention is repetitive Transcranial Magnetic Stimulation (rTMS) and the goal is to reduce alcohol craving with this treatment. The study will enroll 20 Veteran participants. Half of these participants will receive real rTMS and half of the participants will receive placebo rTMS. rTMS treatment will be provided over 10 sessions that will occur once every weekday for 2 weeks. Veteran participants will then complete follow-up phone calls to further evaluate alcohol craving and other symptoms.

Who can participate

Age range22 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * English Speaking * Veterans * Ages 22 through 65 * Meeting AUDIT-C criteria for AUD (4 for men and 3 for women) * Pass MRI screening using the Center for Translational Imaging (CTI) Safety Form. * Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal (CIWA-Ar) scores of 10 Exclusion Criteria: * History of moderate to severe TBI * Documented and verified history of psychotic spectrum disorders (i.e., schizophrenia, bipolar) * Receipt of anti-epileptic medications to control active seizures or evidence of documented seizure within past six months * Receipt of tricyclic anti-depressants, antipsychotic agents, or other drugs that lower the seizure threshold * Current use of: * opiates * cocaine * amphetamines * barbiturates * benzodiazepine * marijuana/cannabis dependence as determined by the SCID-IV * Currently prescribed any anti-craving/addiction medications, i.e.: * naltrexone * varenicline * bupropion * disulfiram * acamprosate * Meet questionable validity or malingering criteria on the Minnesota Multiphasic Personality Inventory-2-RF (MMPI-2-RF; F: T score 107; F(p): T score 85; TRIN: T score 80; VRIN: T score 80) or the Letter Memory Test (LMT; total score 92%), as determined in IRB#13-077 * Pregnant or nursing * Have congestive heart failure * Have cardiac pacemaker or defibrillator, or: * cochlear implant * nerve stimulator * intracranial metal clips * implanted medical pump * increased intracranial …

What they're measuring

Penn Alcohol Craving Scale Change

Timeframe: baseline, immediately after last/10th rTMS session, and 1 day, 1 week, and 1 month follow-up

Total Adverse Event Frequency

Timeframe: immediately after last/10th rTMS session - up to 2 weeks

Total rTMS Sessions Completed

Timeframe: after the 10th and last rTMS treatment session - up to 2 weeks

Trial details

NCT IDNCT03995173

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Alcohol Use Disorder trials