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Theta Burst Stimulation as a Tool to Decrease Drinking in Treatment-seeking Alcohol Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154111
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
There is growing interest in the utilization of transcranial magnetic stimulation (TMS) as a novel, non-pharmacologic approach to decreasing alcohol use among treatment-seeking individuals with Alcohol Use Disorder (AUD). The results of this study will be used to determine which of the 2 proposed TMS strategies has a larger effect on drinking behavior (% days abstinent, % heavy drinking days) as well as alcohol cue-reactivity in a 4 month period. These data will pave the way for TMS to be used as an innovative, new treatment option for individuals with AUD.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Alcohol Abuse Alcohol Dependence Craving Device: Real cTBS to the vmPFC Device: Sham cTBS to the vmPFC Device: Real iTBS to the dlPFC Device: Sham iTBS to the dlPFC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Theta Burst Stimulation as a Tool to Decrease Drinking in Treatment-seeking Alcohol Users
Actual Study Start Date : May 26, 2020
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Real cTBS to the vmPFC
Twenty sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% rMT, MagPro; 600 pulses total)
Device: Real cTBS to the vmPFC
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)

Sham Comparator: Sham cTBS to the vmPFC
Twenty sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% rMT, MagPro; 600 pulses total)
Device: Sham cTBS to the vmPFC
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.

Experimental: Real iTBS to the dlPFC
Twenty sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/ sec for 2 sec, 8 sec rest, 200 pulses/train; 110% rMT, MagPro; 600 pulses total)
Device: Real iTBS to the dlPFC
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).

Sham Comparator: Sham iTBS to the dlPFC
Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/ sec for 2 sec, 8 sec rest, 200 pulses/train; 110% rMT, MagPro; 600 pulses total)
Device: Sham iTBS to the dlPFC
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.




Primary Outcome Measures :
  1. Neuroimaging outcomes: change in drug cue reactivity as specified by changes in BOLD signal [ Time Frame: Baseline visit and 1 month follow-up ]
    The effect of real vs. sham iTBS to the left dlPFC vs. real vs. sham cTBS to the left vmPFC as a tool to modulate the brain response to alcohol cues will be measured using functional MRI BOLD signal and comparing the relative brain reactivity to the alcohol cues in the executive circuit and limbic circuit before and after TMS.

  2. Percent days abstinent [ Time Frame: Through study completion, up to 4 month follow-up ]
    These outcomes will be measured with urine ETG and CDT drug screens collected monthly up to 4 months.

  3. Percentage of heavy drinking days [ Time Frame: Through study completion, up to 4 month follow-up ]
    The percentage of heavy drinking days will be measured by timeline follow-back. Individuals will be asked to track their daily alcohol consumption over the course of the study.


Secondary Outcome Measures :
  1. Changes in Craving [ Time Frame: Baseline visit, 1-4 month follow-ups ]
    Additional craving assessments will be measured through the study as well to detect any changes in craving for alcohol. The alcohol urge questionnaire will be asked prior to TMS administration and at the follow-up visits. This is a scale based on the individuals craving at that moment on a scale of 1-7.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 21- 65 (to maximize participation from the cohort of individuals seeking alcohol treatment through intensive outpatient programs: Scalp- to-Cortex distance will be included as a covariate to calculate adjusted TMS dose given expected cortical atrophy in heavy alcohol users and older adults).
  2. Meets the DSM V criteria for having a current AUD, determined by DSM- V criteria, using the Structured Clinical Interview for DSM-V.
  3. Currently enrolled or scheduled to enroll in intensive outpatient program affiliated with Wake Forest University (WFU). Subjects who withdraw from the treatment program will no longer be allowed to participate in the study.
  4. Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 2 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5 for men) during the 30-days prior to enrolling in the intensive outpatient program.
  5. Able to read and understand questionnaires, assessments, and the informed consent.
  6. No elevated risk of seizure (i.e., CIWA questionnaire <5, does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold).
  7. Not currently prescribed chlorpromazine, clozapine, olanzapine, aminophylline, pethidine, fentanyl due to their effects on cortical excitability.
  8. No presence of metal objects in the head/neck.
  9. No history of traumatic brain injury, including a head injury which resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.
  10. No history or current diagnosis of claustrophobia leading to significant clinical symptoms of anxiety.

Exclusion Criteria:

  1. Currently meets DSM V criteria for moderate or severe substance use disorder in the past six months for any psychoactive substance other than alcohol.
  2. Any psychoactive substance use (except marijuana and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels.
  3. Meets DSM V criteria for current axis I disorders of panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder or organic mental disorder. [Note: The inclusion of subjects with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD at large (including those in the outpatient program).
  4. Has current suicidal ideation or homicidal ideation.
  5. Is currently taking or initiates a medication known to affect alcohol intake and/or craving (e.g., disulfiram. naltrexone, acamprosate, topiramate). [Note: This exclusionary criterion is for scientific rather than safety or patient comfort reasons. Although some physicians involved in intensive outpatient programs prescribe naltrexone as applicable to patients, many individuals are not interested in medication management. In the pilot study included in the Research Strategy only 2 of the 42 individuals who enrolled in the study were given naltrexone at any point during the outpatient program or in aftercare].
  6. Has a clinically significant medical problem such as cardiovascular, renal, GI, or endocrine problems that would impair participation.
  7. Females of childbearing potential who are pregnant (by urine HCG), planning to become pregnant, nursing, or who are not using a reliable form of birth control.
  8. Unstable living situation.
  9. Suffers from chronic migraines.
  10. Has metal placed above the neck.
  11. Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold).
  12. History of claustrophobia.
  13. History of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, and/or having ever been informed he/she has an epidural, subdural, or subarachnoid hemorrhage.
  14. Presence of history of an unstable medical illness requiring planned medical/surgical intervention (e.g. chemotherapy, surgical procedure).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154111


Contacts
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Contact: Colleen Hanlon, PhD 843-792-5732 chanlon@wakeforest.edu
Contact: Julia Imperatore, BS 843-792-5560 imperato@musc.edu

Locations
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United States, North Carolina
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Colleen Hanlon, PhD    843-792-5732    chanlon@wakehealth.edu   
Principal Investigator: Colleen Hanlon, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Colleen Hanlon, PhD Wake Forest University
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04154111    
Other Study ID Numbers: IRB00061760
1R01AA027705-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared. All data is de-identified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Transcranial Magnetic Stimulation
Brain Stimulation
Treatment
Neuroimaging
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders