Frontal-Striatal Reward Circuit Neuromodulation and Alcohol Self-Administration
Stopped early · Not applicable · Has a placebo group
Conditions studied: Alcohol Use Disorder
In brief
This will be a single site randomized, 2-session, within-subject cross-over design pilot study. 20 enrolled (of 30 consented) subjects reporting varying levels of binge and high intensity drinking, defined as at least 2 episodes of drinking 4 (for women) or 5 (for men) drinks on an occasion over the last 5 weeks, (unless determined by PI that drinking history meets study objectives), will be enrolled. Subjects will be randomized to undergo one session of repetitive transcranial magnetic stimulation (rTMS) or sham immediately followed by the investigators rate control intravenous (IV) alcohol self-administration (ASA) paradigm. Subjects will then return 7-14 days later and undergo the same sequence of events with the opposite intervention (i.e. rTMS or sham) from session 1.
Key facts
- Study ID
- NCT04971681
- Run by
- Indiana University
- People needed
- 9
- Starts
- 2021-10-08
- Expected to finish
- 2022-06-02
- Last updated by the study team
- 2025-01-13
Who can join
Age: 21 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Overtly healthy men and women aged 21 - 35
- Able to give informed consent
- Able to understand/complete questionnaires and procedures in English
- Willing and able to adhere to the study schedule
- At least 2 binge drinking events (at least 4 or 5 drinks on a drinking day for women and men respectively over the last 5 weeks, unless determined by study physicians that drinking history meets study objectives
- Have venous access sufficient to allow blood sampling
You may not qualify if…
- Pregnant or breast-feeding
- Desire to be treated for any substance use disorder or court ordered to not drink alcohol
- Medical disorders or other conditions, such as lifetime history of a seizure, including history of Electroconvulsive therapy (ECT) but excluding febrile seizures and those induced by substance withdrawal, that may influence study outcome or subject safety
- First degree relative with idiopathic epilepsy or other seizure disorder
- Diagnostic and Statistical Manual (DSM) 5 Disorders (non-AUD) or current/history of neurological disease of cerebral origin, or head injury with > 20 min loss of consciousness, if determined by the study physicians to affect subject safety or data integrity
- Positive urine drug screen for amphetamines/ methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine if determined by the study physicians to adversely affect subject safety or data integrity
- Medications (past 30 days) that could influence subject data/subject safety (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by study physicians
- Positive BrAC reading at beginning of any study session
- Actively suicidal (for example, any suicide attempts within the past 3 months or any current suicidal intent, including a plan) or are at serious suicidal risk, by clinical judgment of the study physicians
- Any condition for which the study physicians determine it is unsafe or not prudent to enroll a subject
Where it is running
- Neural Systems Lab — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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