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Terminated
NCT03995173
Pilot rTMS for AUD+mTBI
Conditions: Alcohol Use Disorder, Mild Traumatic Brain Injury, Post-traumatic Stress Disorder
Sex: All
Ages: 22 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 2
Sponsor: VA Office of Research and Development
Location: Edward Hines Jr. VA Hospital, Hines, IL Hines Illinois
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.
Eligibility Criteria
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 pressure
* History of:
* surgery on blood vessels in brain and/or valves of the heart
* brain hemorrhage
* neurovascular conditions
* neurodegenerative disorders
* claustrophobia
* metal in eye/face
* shrapnel/bullet remnants in brain
* Actively suicidal as evidenced by plan to harm or recent attempt communicated on the BDI-II or electronic medical record within the past 6 months
* History of mild TBI within the last 3 months
Source: ClinicalTrials.gov (NCT03995173). StuddyBuddy aggregates publicly available trial information.