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Behavioural Intervention
TMS for Cocaine Use Disorder
Phase 4
Recruiting
Led By Yihong Yang, Ph.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 - 60 years of age.
No history of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, mitral valve prolapse, or any heart condition currently under medical care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each visit
Awards & highlights
Study Summary
This trial is testing if a brain stimulation technique called iTBS can help reduce cocaine use. Healthy adults ages 18-60 who do or do not have cocaine use disorder are eligible. The study includes questionnaires, medical history and physical exams, blood and urine tests, and alcohol breath tests. In the pilot study, 10 participants with cocaine use disorder will have 10 treatment days over 2 weeks. Half will be inpatient and half will be outpatient. They will have 2 follow-up visits. Treatment includes: iTBS- a coil is placed on the head and a brief electrical current passes through the coil while they view cocaine-related images during each session
Who is the study for?
This trial is for right-handed adults aged 18-60, who are currently struggling with moderate to severe cocaine use disorder and haven't been abstinent for a month in the past year. Participants should be in good health, not using certain medications or have specific medical conditions like heart disease or neurological disorders. Pregnant women and those at risk of pregnancy without contraception are excluded.Check my eligibility
What is being tested?
The study tests intermittent theta-burst stimulation (iTBS), a type of brain stimulation therapy, to see if it can reduce cocaine use. Participants will undergo iTBS while viewing cocaine-related images over several sessions, with follow-ups including MRI scans to observe changes in the brain and heart due to treatment.See study design
What are the potential side effects?
Potential side effects from iTBS may include discomfort at the site of stimulation on the head, headache, lightheadedness, or seizures although rare. The procedure is generally considered safe but might not be suitable for individuals with certain metal implants or serious cardiac conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
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I have no history of serious heart conditions or strokes.
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I don't have any implants or metal objects in my body that could interfere with iTBS treatment.
Select...
I haven't participated in any brain stimulation sessions recently.
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I do not have hearing loss or ringing in my ears caused by loud noises.
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My immediate family has no history of hereditary neurological disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tbs, mri sessions
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tbs, mri sessions
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dental Plaque
Cocaine
Secondary outcome measures
To monitor safety of iTBS applied in cocaine dependent individuals.
Side effects data
From 2018 Phase 1 & 2 trial • 92 Patients • NCT0052013064%
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 with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
20%
Infection::Blood
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%
Death not associated with CTCAE term::Death NOS
9%
Neuropathy: sensory
9%
Dry mouth/salivary gland (xerostomia)
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%
FEV(1)
5%
Neuropathy: motor
5%
Pain::Head/headache
5%
Pericardial effusion (non-malignant)
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
5%
Pain::Muscle
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%
Death not associated with CTCAE term::Multi-organ failure
2%
Supraventricular and nodal arrhythmia::Sinus tachycardia
2%
Myocarditis
2%
Dermatology/Skin - Other (Deep sclerosis per MRI, GVHD possible)
2%
Cardiac ischemia/infarction
2%
Glucose, serum-high (hyperglycemia)
2%
Dry skin
2%
Pain::Back
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
2%
Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)
2%
Infection ::Eye NOS
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
2%
Perforation, GI::Small bowel NOS
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
2%
Infection with unknown ANC::Colon
2%
Cystitis
2%
Infection with unknown ANC::Catheter-related
2%
Memory impairment
2%
Cardiopulmonary arrest, cause unknown (non-fatal)
2%
Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)
2%
Infection::Skin (cellulites)
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
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: PilotExperimental Treatment1 Intervention
P1 is designed to establish safety and tolerability criteria for administering iTBS to treatment seeking cocaine users, initially as in-patient followed by an out-patient cohort
Group II: Healthy Control-Main (EFS)Experimental Treatment1 Intervention
Population comparison of acute experimental iTBS.
Group III: Cocaine - Active (EFS)Experimental Treatment1 Intervention
designed to implement the iTBS administration parameters established from P1 with a larger sample of treatment seeking CD participants. Though the schedule may change slightly based on the outcome of the pilot, a schedule of 3 daily iTBS sessions with a 20 minute interval between administrations is planned and used throughout the design.
Group IV: Cocaine - Sham (EFS)Placebo Group1 Intervention
To test the efficacy of the iTBS.
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?
National Institute on Drug Abuse (NIDA)Lead Sponsor
2,501 Previous Clinical Trials
2,624,472 Total Patients Enrolled
Yihong Yang, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
2 Previous Clinical Trials
820 Total Patients Enrolled
Elliot Stein, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
24 Previous Clinical Trials
3,230 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You should be in overall good physical condition.I am between 18 and 60 years old.You have a pacemaker, defibrillator, or any other implanted device that might cause issues during the study procedures. You also have metal objects in your body that prevent the use of iTBS administration and MRI scanning.I can provide a government-issued ID.I have no history of serious heart conditions or strokes.I am seeking treatment for a moderate to severe cocaine use disorder.I don't have any implants or metal objects in my body that could interfere with iTBS treatment.I am not pregnant, breastfeeding, or at risk of becoming pregnant without using effective birth control.I have a history of neurological issues that could increase my risk of seizures.I haven't used any experimental drugs or certain medications in the recent past.You are right-handed.You do not have a learning disability, ADHD, or any other condition that affects your ability to think or learn.You have not received any brain stimulation treatment for at least two weeks before starting the study, and you have not received any such treatment for the last six months for treatment purposes.I haven't participated in any brain stimulation sessions recently.Be fit and healthy.You are right-handed.I do not have hearing loss or ringing in my ears caused by loud noises.I have a severe addiction to a substance not including cocaine, nicotine, marijuana, or opiates.My immediate family has no history of hereditary neurological disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Cocaine - Active (EFS)
- Group 2: Cocaine - Sham (EFS)
- Group 3: Healthy Control-Main (EFS)
- Group 4: Pilot
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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