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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 below
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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.
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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 weeks
Treatment ~ Varies
Follow Up ~tbs, mri sessions
This trial's timeline: 3 weeks for screening, Varies for treatment, and tbs, mri sessions for reporting.

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 • 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 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%
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
9%
Dry mouth/salivary gland (xerostomia)
9%
Neuropathy: sensory
9%
Dyspnea (shortness of breath)
9%
Death not associated with CTCAE term::Death 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%
Neuropathy: motor
5%
Pericardial effusion (non-malignant)
5%
Pain::Head/headache
5%
Pain::Muscle
5%
FEV(1)
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
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%
Infection with unknown ANC::Catheter-related
2%
Memory impairment
2%
Myocarditis
2%
Cardiac ischemia/infarction
2%
Perforation, GI::Small bowel NOS
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
2%
Glucose, serum-high (hyperglycemia)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
2%
Dry skin
2%
Supraventricular and nodal arrhythmia::Sinus tachycardia
2%
Pain::Back
2%
Cardiopulmonary arrest, cause unknown (non-fatal)
2%
Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)
2%
Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)
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 with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
2%
Cystitis
2%
Infection::Skin (cellulites)
2%
Infection ::Eye 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

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
2,469 Previous Clinical Trials
2,619,254 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

Theta-Burst Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02927236 — Phase 4
Cocaine Use Disorder Research Study Groups: Cocaine - Active (EFS), Cocaine - Sham (EFS), Healthy Control-Main (EFS), Pilot
Cocaine Use Disorder Clinical Trial 2023: Theta-Burst Stimulation Highlights & Side Effects. Trial Name: NCT02927236 — Phase 4
Theta-Burst Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02927236 — Phase 4

Frequently Asked Questions

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

Have any governmental entities recognized the efficacy of Transcranial Magnetic Stimulation?

"According to our internal assessment, transcranial magnetic stimulation (TMS) can be rated a 3 on the safety scale because it has received approval for Phase 4 trials."

Answered by AI

How many participants are included in this medical experiment?

"Affirmative. Clinicaltrials.gov states that the trial, which was initially posted on February 13th 2017, is still recruiting participants. 170 people are needed across one medical centre for this experiment to reach completion."

Answered by AI

Is the eligibility threshold for this clinical trial older than 35 years?

"The minimum age for inclusion in this trial is 18, while the upper limit of participation is 60 years old."

Answered by AI

Is recruitment for this trial ongoing or has it been completed?

"Affirmative. Clinicaltrials.gov records that this clinical trial, which has been available since February 13th of 2017, is still recruiting participants - a total of 170 from one location at present."

Answered by AI

Are there any qualifications for being a participant in this clinical experiment?

"This clinical trial is seeking 170 individuals aged 18-60 who have been diagnosed with a cocaine use disorder. Prospective participants must meet the following requirements: Be between these ages, be right-handed, and present acceptable forms of identification such as driver's license or birth certificate. Additionally, applicants will be required to participate in screening via self-reporting."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
How old are they?
18 - 65
What site did they apply to?
National Institute on Drug Abuse
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

A friend told me about it. I have been dependent on cicaine for 3 years now and have wanted to stop. Doing this trial may help with that and also help with others in the future giving them a second chance and stop substance abuse.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use
2017. "Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02927236.
~13 spots leftby Dec 2024
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