Frontal-Striatal Reward Circuit Neuromodulation and Alcohol Self-Administration

NCT04971681 | Terminated Results DMC FDA Device

• 2 other identifiers: 11511P60AA007611
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• T80

  The amount of time subjects take to self-administer enough alcohol to raise their breath alcohol concentration (BrAC) to 80 mg/dL

  90 min

Secondary Outcomes (1)

• Alcohol Consumption (Drinks/Week)

  5 weeks

Study Arms (2)

Low frequency repetitive transcranial magnetic stimulation (rTMS)

EXPERIMENTAL

Low frequency repetitive transcranial magnetic stimulation (rTMS)

Device: Low frequency repetitive transcranial magnetic stimulation (rTMS); Device: Sham

Sham rTMS Stimulation

SHAM COMPARATOR

Sham rTMS Stimulation

Device: Low frequency repetitive transcranial magnetic stimulation (rTMS); Device: Sham

Interventions

Low frequency repetitive transcranial magnetic stimulation (rTMS) DEVICE

Subjects will receive one session of low frequency repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC), within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 110% of motor threshold (MT), for a total of 1200 pulses

Low frequency repetitive transcranial magnetic stimulation (rTMS); Sham rTMS Stimulation

Sham DEVICE

The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.

Low frequency repetitive transcranial magnetic stimulation (rTMS); Sham rTMS Stimulation

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Neural Systems Lab

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Martin H. Plawecki, MD, PhD
• Organization: Indiana University

mplaweck@iu.edu

3179486550

Study Officials

• Susan Conroy, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: October 8, 2021
• Primary Completion: April 25, 2022
• Study Completion: June 2, 2022
• Last Updated: January 13, 2025
• Results First Posted: July 16, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)