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Non-invasive Brain Stimulation Technique

TMS A for Alcoholism (TAM Trial)

N/A
Recruiting
Led By Samantha J Fede, PhD
Research Sponsored by Auburn University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or Older
(Drinker Group): Reports consuming 4 [if female]/ 5 [if male] or more standard drinks on one occasion at least 2 times a month AND/OR reports consuming more than 7 [if female]/ 14 [if male] standard drinks per week on average
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately following tms a, immediately following tms b
Awards & highlights

TAM Trial Summary

This trial looks at how attention processes affect brain engagement when experiencing emotions & social cognition, & if it’s associated with alcohol intake. 19+ people in Auburn/Opelika area invited. Involves 3 study visits of 2 hrs each & MRI, TMS scans.

Who is the study for?
This study is for adults aged 19 or older in the Auburn/Opelika area. It includes two groups: those who drink alcohol frequently (4 or more drinks at least twice a month for women, 5 or more for men) and those who rarely drink. Participants must be able to undergo MRI scans and TMS sessions without health risks.Check my eligibility
What is being tested?
The trial investigates how attention affects brain activity related to emotions and social understanding, especially in relation to alcohol consumption. It involves three visits over a month with MRIs and non-invasive brain stimulation called TMS.See study design
What are the potential side effects?
TMS may cause discomfort at the stimulation site, headache, lightheadedness, or tingling. Rarely it can induce seizures but this is uncommon especially if participants don't have any predisposing factors.

TAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I drink more than the recommended weekly limit for my gender.

TAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately following tms a, immediately following tms b
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately following tms a, immediately following tms b for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in attention switching
Change in cue reactivity
Change in sociomoral attention switching
Secondary outcome measures
Brain Chemistry
Change in brain activity during cue reactivity
Change in brain activity during sociomoral attention switching

Side effects data

From 2018 Phase 1 & 2 trial • 92 Patients • NCT00520130
64%
ALT, SGPT (serum glutamic pyruvic transaminase)
61%
Leukocytes (total WBC)
61%
Lymphopenia
59%
Neutrophils/granulocytes (ANC/AGC)
59%
Hemoglobin
59%
AST, SGOT(serum glutamic oxaloacetic transaminase)
57%
Platelets
45%
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
45%
Diarrhea
45%
Phosphate, serum-low (hypophosphatemia)
43%
Rash/desquamation
36%
Nausea
30%
Magnesium, serum-high (hypermagnesemia)
27%
Bilirubin (hyperbilirubinemia)
23%
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
23%
Renal failure
23%
Potassium, serum-low (hypokalemia)
23%
Mucositis/stomatitis (clinical exam)::Oral cavity
20%
Infection::Blood
20%
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
20%
Albumin, serum-low (hypoalbuminemia)
20%
Creatinine
18%
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
18%
Dry eye syndrome
16%
Alkaline phosphatase
16%
Hypoxia
14%
Thrombosis/thrombus/embolism
14%
Febrile neutropenia
14%
Infection ::Lung (pneumonia)
14%
Infection with unknown ANC::Upper airway NOS
14%
Sodium, serum-low (hyponatremia)
14%
Infection ::Bladder (urinary)
11%
Colitis, infectious (e.g., Clostridium difficile)
11%
PTT (Partial Thromboplastin Time)
9%
Dry mouth/salivary gland (xerostomia)
9%
Neuropathy: sensory
9%
Death not associated with CTCAE term::Death NOS
9%
Dyspnea (shortness of breath)
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
9%
Induration/fibrosis (skin and subcutaneous tissue)
9%
Infection with unknown ANC::Blood
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
9%
Hyperpigmentation
9%
Renal/Genitourinary - Other (insufficiency)
9%
Uric acid, serum-high (hyperuricemia)
7%
Dysphagia (difficulty swallowing)
7%
Gastritis (including bile reflux gastritis)
7%
GGT (gamma-Glutamyl transpeptidase)
7%
Heartburn/dyspepsia
7%
Death not associated with CTCAE term::Disease progression NOS
7%
Carbon monoxide diffusion capacity (DL(co))
7%
Hemorrhage, GU::Bladder
7%
Hypertension
7%
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
7%
Magnesium, serum-low (hypomagnesemia)
7%
Pancreatic endocrine: glucose intolerance
7%
Rash: acne/acneiform
7%
Infection ::Blood
7%
Infection with normal ANC or Grade 1 or 2 neutrophils::Brain (encephalitis, infectious)
7%
Supraventricular and nodal arrhythmia::Atrial fibrillation
7%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
7%
Renal/Genitourinary - Other (acute renal injury)
7%
Potassium, serum-high (hyperkalemia)
7%
Hypotension
7%
Pleural effusion (non-malignant)
5%
Pain::Muscle
5%
Neuropathy: motor
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
5%
Pain::Head/headache
5%
FEV(1)
5%
Pericardial effusion (non-malignant)
5%
Infection::Sinus
5%
Left ventricular systolic dysfunction
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Nose
5%
Allergic reaction/hypersensitivity (including drug fever)
5%
Infection ::Urinary tract NOS
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
5%
Infection with unknown ANC::Lung (pneumonia)
5%
Pneumonitis/pulmonary infiltrates
5%
Thrombosis/embolism (vascular access-related)
5%
Anorexia
5%
Dermatology/Skin - Other (GVHD; cGVHD)
5%
Fatigue (asthenia, lethargy, malaise)
5%
Infection ::Colon
5%
Infection - Other (Varicella zoster; noravirus)
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
5%
Metabolic/Laboratory - Other (pancytopenia; steroid induced hyperglycemia)
5%
Vaginal dryness
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
5%
Gastrointestinal - Other (GVHD)
5%
Infection::Bronchus
5%
Infection Sinus
5%
Ulceration
5%
Vomiting
5%
Thrombotic microangiopathy
5%
Infection::Urinary tract NOS
5%
Mood alteration::Anxiety
5%
Pain::Anus
2%
Cardiac ischemia/infarction
2%
Memory impairment
2%
Supraventricular and nodal arrhythmia::Sinus tachycardia
2%
Infection with unknown ANC::Catheter-related
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
2%
Cystitis
2%
Glucose, serum-high (hyperglycemia)
2%
Myocarditis
2%
Cardiopulmonary arrest, cause unknown (non-fatal)
2%
Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)
2%
Perforation, GI::Small bowel NOS
2%
Dry skin
2%
Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)
2%
Pain::Back
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
2%
Dermatology/Skin - Other (Deep sclerosis per MRI, GVHD possible)
2%
Death not associated with CTCAE term::Multi-organ failure
2%
Infection with unknown ANC::Colon
2%
Infection ::Eye NOS
2%
Infection::Skin (cellulites)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
2%
Bronchospasm, wheezing
2%
Renal/Genitourinary - Other (dysuria; hematuria; stent replacement)
2%
Liver dysfunction/failure (clinical)
2%
Esophagitis
2%
Renal/Genitourinary - Other (fluid overload refractory to normal doses of Lasix)
2%
Arthritis (non-septic)
2%
Cholecystitis
2%
Infection::Rectum
2%
Infection ::Trachea
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Esophagus
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Heart (endocarditis)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Liver
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Meninges (meningitis)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal
2%
Pain::Abdomen NOS
2%
Rash: hand-foot skin reaction
2%
Ulcer, GI::Duodenum
2%
Bicarbonate, serum-low
2%
CPK (creatine phosphokinase)
2%
Cardiac General - Other (heart failure, fluid overload)
2%
Fibrinogen
2%
Fistula, GI::Anus
2%
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
2%
Hemorrhage, GI::Abdomen NOS
2%
Infection ::Catheter-related
2%
Infection::Soft tissue NOS
2%
Infection ::Upper aerodigestive NOS
2%
Infection:: Upper airway NOS
2%
Infection with unknown ANC::Sinus
2%
Infection with unknown ANC::Urinary tract NOS
2%
Infection with unknown ANC::Wound
2%
Iron overload
2%
Lipase
2%
Pain::Throat/pharynx/larynx
2%
Pain::Urethra
2%
Prolonged QTc interval
2%
Psychosis (hallucinations/delusions)
2%
Pulmonary/Upper Respiratory - Other (infiltrates; fungal pneumonia)
2%
Renal/Genitourinary - Other (dysuria)
2%
Renal/Genitourinary - Other (hematuria)
2%
Secondary Malignancy - possibly related to cancer treatment (squamous cell carcinoma lip)
2%
Vaginal mucositis
2%
Confusion
2%
Edema: limb
2%
Edema: viscera
2%
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
2%
Infection::Catheter-related
2%
Left ventricular diastolic dysfunction
2%
Stricture/stenosis (including anastomotic), GI::Esophagus
2%
Amylase
2%
Cardiac General - Other (cardimyopathy)
2%
Colitis
2%
Encephalopathy
2%
Hemorrhage, GI::Anus
2%
Hemorrhage, GI::Lower GI NOS
2%
Secondary Malignancy - possibly related to cancer treatment (mucoepidermoid carcinoma)
2%
Skin breakdown/decubitus ulcer
2%
Sodium, serum-high (hypernatremia)
2%
Triglyceride, serum-high (hypertriglyceridemia)
2%
Urinary frequency/urgency
2%
Urinary retention (including neurogenic bladder)
2%
Weight loss
2%
Infection::Meninges (meningitis)
2%
Adult Respiratory Distress Syndrome (ARDS)
2%
Alkalosis (metabolic or respiratory)
2%
Insomnia
2%
Joint-function
2%
Hemorrhage, pulmonary/upper respiratory::Lung
2%
Infection - Other
2%
Adrenal insufficiency
2%
Cough
2%
Mood alteration::Depression
2%
Ophthalmoplegia/diplopia (double vision)
2%
Osteonecrosis (avascular necrosis)
2%
Phlebitis (including superficial thrombosis)
100%
80%
60%
40%
20%
0%
Study treatment Arm
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm
B - Cyclosporine (AC) Arm

TAM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TMS AExperimental Treatment1 Intervention
TMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI
Group II: TMS BActive Control1 Intervention
TMS administered over right frontal eye field at 1 Hz, 110% of MT, 7 x 225 sec trains, 30 sec ITI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TMS
2021
Completed Phase 2
~2170

Find a Location

Who is running the clinical trial?

Auburn UniversityLead Sponsor
72 Previous Clinical Trials
14,365 Total Patients Enrolled
2 Trials studying Alcoholism
177 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
796 Previous Clinical Trials
1,361,383 Total Patients Enrolled
421 Trials studying Alcoholism
984,945 Patients Enrolled for Alcoholism
Samantha J Fede, PhDPrincipal InvestigatorPrincipal Investigator
1 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Alcoholism
90 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been recruited to take part in this medical research?

"Affirmative. According to the available data on clinicaltrials.gov, this research project is in its recruitment phase with 40 subjects sought from a single location. The trial was first shared on August 11th 2022 and most recently updated on November 3rd of that same year."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
Texas
What site did they apply to?
Auburn University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Auburn University: < 48 hours
Average response time
  • < 2 Days
~11 spots leftby Dec 2024