TMS for Cocaine Use Disorders

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
National Institute on Drug Abuse, Baltimore, MD
Cocaine Use Disorders+2 More
TMS - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use

See full description

Eligible Conditions

  • Cocaine Use Disorders
  • Dependence, Cocaine

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Cocaine Use Disorders

Study Objectives

This trial is evaluating whether TMS will improve 2 primary outcomes and 1 secondary outcome in patients with Cocaine Use Disorders. Measurement will happen over the course of TBS, MRI sessions.

TBS sessions
Pilot - To establish tolerability of 3 daily iTBS sessions with an inter-session interval of 60 minutes in cocaine dependent participants. This Pilot is also designed for gathering preliminary data on the effectiveness of iTBS as a treatment for...
TBS, MRI sessions
Main Study -to characterize cue reactivity, reward processing, executive control, intrinsic network connectivity, and cardiac (specifically soft plaques) differences between healthy controls and cocaine dependent participants at baseline, during...
each visit
To monitor safety of iTBS applied in cocaine dependent individuals.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Cocaine Use Disorders

Side Effects for

B - Cyclosporine (AC) Arm
Lymphopenia
60%
Neutrophils/granulocytes (ANC/AGC)
60%
Rash/desquamation
58%
Hemoglobin
58%
Leukocytes (total WBC)
58%
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
56%
Platelets
51%
AST, SGOT(serum glutamic oxaloacetic transaminase)
51%
Phosphate, serum-low (hypophosphatemia)
49%
Diarrhea
49%
Potassium, serum-low (hypokalemia)
38%
ALT, SGPT (serum glutamic pyruvic transaminase)
38%
Bilirubin (hyperbilirubinemia)
36%
Magnesium, serum-high (hypermagnesemia)
36%
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
29%
Albumin, serum-low (hypoalbuminemia)
27%
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
27%
Infection::Blood
24%
Creatinine
22%
Potassium, serum-high (hyperkalemia)
22%
Death not associated with CTCAE term::Disease progression NOS
22%
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
20%
Sodium, serum-low (hyponatremia)
20%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
20%
Magnesium, serum-low (hypomagnesemia)
20%
Febrile neutropenia
20%
Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
20%
PTT (Partial Thromboplastin Time)
18%
Infection ::Blood
18%
Hypoxia
18%
Colitis, infectious (e.g., Clostridium difficile)
16%
Death not associated with CTCAE term::Death NOS
16%
Uric acid, serum-high (hyperuricemia)
16%
Hypertension
16%
Renal failure
13%
Infection ::Lung (pneumonia)
13%
Nausea
13%
Renal/Genitourinary - Other (failure; hematuria; insufficiency; dysuria)
13%
Alkaline phosphatase
13%
Adult Respiratory Distress Syndrome (ARDS)
11%
Hypotension
11%
Pneumonitis/pulmonary infiltrates
11%
Carbon monoxide diffusion capacity (DL(co))
11%
Fatigue (asthenia, lethargy, malaise)
11%
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
11%
Infection::Catheter-related
9%
Thrombotic microangiopathy
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
9%
Left ventricular systolic dysfunction
9%
Secondary Malignancy - possibly related to cancer treatment (AML);
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
9%
Dyspnea (shortness of breath)
7%
Colitis
7%
Mood alteration::Depression
7%
Encephalopathy
7%
Hemorrhage, GI::Lower GI NOS
7%
Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
7%
Infection ::Colon
7%
GGT (gamma-Glutamyl transpeptidase)
7%
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
7%
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
7%
Infection ::Bladder (urinary)
7%
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
7%
Ulceration
4%
Pruritus/itching
4%
Thrombosis/embolism (vascular access-related)
4%
Hemorrhage, CNS
4%
Infection - Other
4%
Dry eye syndrome
4%
Bicarbonate, serum-low
4%
Calcium, serum-low (hypocalcemia)
4%
Thrombosis/thrombus/embolism
4%
Calcium, serum-high (hypercalcemia)
4%
Dysphagia (difficulty swallowing)
4%
Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal
4%
Anorexia
4%
Infection::Sinus
4%
Mood alteration::Anxiety
4%
Vaginal dryness
4%
Neuropathy: motor
4%
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
4%
Pain::Head/headache
4%
Pleural effusion (non-malignant)
4%
Death not associated with CTCAE term::Multi-organ failure
4%
Infection with unknown ANC::Blood
4%
Supraventricular and nodal arrhythmia::Sinus tachycardia
4%
Myositis (inflammation/damage of muscle)
4%
Hiccoughs (hiccups, singultus)
4%
Infection with unknown ANC::Upper airway NOS
4%
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
4%
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
4%
Cholecystitis
2%
Muscle weakness, generalized or specific area (not due to neuropathy)::Right-sided
2%
Hemorrhage, GI::Duodenum
2%
Right ventricular dysfunction (cor pulmonale)
2%
Infection::Bronchus
2%
Infection - Other (CMV reactivation)
2%
Liver dysfunction/failure (clinical)
2%
Pulmonary/Upper Respiratory - Other (infiltrates)
2%
Rash: hand-foot skin reaction
2%
Dermatology/Skin - Other (MRSA abscess)
2%
Adrenal insufficiency
2%
Heartburn/dyspepsia
2%
Esophagitis
2%
CNS cerebrovascular ischemia
2%
Renal/Genitourinary - Other (AKI, required CVVH)
2%
Infection with unknown ANC::Bronchus
2%
Hemorrhage, GI::Abdomen NOS
2%
Somnolence/depressed level of consciousness
2%
Confusion
2%
Leukoencephalopathy (radiographic findings)
2%
Infection with unknown ANC::Catheter-related
2%
Pneumothorax
2%
Rash: acne/acneiform
2%
Seizure
2%
Syndromes - Other (septic shock)
2%
Taste alteration (dysgeusia)
2%
Wound complication, non-infectious
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Liver
2%
Pain::Joint
2%
Infection with unknown ANC::Skin (cellulites)
2%
CPK (creatine phosphokinase)
2%
Obstruction, GU::Bladder
2%
Thyroid function, low (hypothyroidism)
2%
Infection ::Brain + Spinal cord (encephalomyelitis)
2%
Infection::Oral cavity-gums (gingivitis)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Vagina
2%
Infection Sinus
2%
Neurology - Other (delirium)
2%
Cognitive disturbance
2%
Infection:: Abdomen NOS
2%
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
2%
Infection::Nose
2%
Infection with unknown ANC::Lung (pneumonia)
2%
Pain::Back
2%
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
2%
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
2%
Syncope (fainting)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Penis
2%
Infection ::Upper aerodigestive NOS
2%
Infection
2%
Iron overload
2%
Ataxia (incoordination)
2%
Edema: head and neck
2%
Cystitis
2%
Hemorrhage, pulmonary/upper respiratory::Nose
2%
Ocular/Visual - Other
2%
Prolonged QTc interval
2%
Infection::Upper airway NOS
2%
Pancreatic endocrine: glucose intolerance
2%
Infection ::Wound
2%
Infection ::Lip/perioral
2%
Cytokine release syndrome/acute infusion reaction
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Nose
2%
Pericardial effusion (non-malignant)
2%
Pericarditis
2%
Neuropathy: sensory
2%
Opportunistic infection associated with >=Grade 2 Lymphopenia
2%
Skin breakdown/decubitus ulcer
2%
Sodium, serum-high (hypernatremia)
2%
Rigors/chills
2%
Hemorrhage, GI::Rectum
2%
Hemorrhage, pulmonary/upper respiratory::Lung
2%
Hemorrhage, GI::Upper GI NOS
2%
Infection ::Urinary tract NOS
2%
Left ventricular diastolic dysfunction
2%
Musculoskeletal/Soft Tissue - Other
2%
Infection ::Muscle (infection myositis)
2%
FEV(1)
2%
Dizziness
2%
Weight gain
2%
Tumor lysis syndrome
2%
Ventricular arrhythmia::Ventricular tachycardia
2%
Amylase
2%
Cardiac ischemia/infarction
2%
Edema: limb
2%
Bronchospasm, wheezing
2%
Gastrointestinal - Other
2%
Hemorrhage, GU::Urinary NOS
2%
Supraventricular and nodal arrhythmia::Supraventricular tachycardia
2%
Dry skin
2%
Pulmonary/Upper Respiratory - Other (pleural thickening)
2%
Acidosis (metabolic or respiratory)
2%
Dry mouth/salivary gland (xerostomia)
2%
Infection::Brain (encephalitis, infectious)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea
2%
Infection - Other (acinetobacter)
2%
Infection - Other (dissiminated HSV)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva
2%
Infection - Other (Rhinovirus, Coronavirus HKU1)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS
2%
Infection with unknown ANC::Upper aerodigestive NOS
2%
Allergic reaction/hypersensitivity (including drug fever)
0%
Edema: viscera
0%
Memory impairment
0%
Gastritis (including bile reflux gastritis)
0%
Phlebitis (including superficial thrombosis)
0%
Infection::Soft tissue NOS
0%
Infection - Other (Varicella zoster; noravirus)
0%
Dermatology/Skin - Other (GVHD; cGVHD)
0%
Ophthalmoplegia/diplopia (double vision)
0%
Renal/Genitourinary - Other (acute renal injury)
0%
Infection:: Upper airway NOS
0%
Osteonecrosis (avascular necrosis)
0%
Lipase
0%
Insomnia
0%
Pain::Muscle
0%
Pain::Urethra
0%
Infection with unknown ANC::Sinus
0%
Pain::Abdomen NOS
0%
Infection::Rectum
0%
Infection with normal ANC or Grade 1 or 2 neutrophils::Meninges (meningitis)
0%
Ulcer, GI::Duodenum
0%
Pain::Throat/pharynx/larynx
0%
Pain::Anus
0%
Perforation, GI::Small bowel NOS
0%
Renal/Genitourinary - Other (dysuria; hematuria; stent replacement)
0%
Secondary Malignancy - possibly related to cancer treatment (squamous cell carcinoma lip)
0%
Cardiac General - Other (cardimyopathy)
0%
Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)
0%
Pulmonary/Upper Respiratory - Other (infiltrates; fungal pneumonia)
0%
Renal/Genitourinary - Other (fluid overload refractory to normal doses of Lasix)
0%
Renal/Genitourinary - Other (hematuria)
0%
Secondary Malignancy - possibly related to cancer treatment (mucoepidermoid carcinoma)
0%
Dermatology/Skin - Other (Deep sclerosis per MRI, GVHD possible)
0%
Gastrointestinal - Other (GVHD)
0%
Infection::Meninges (meningitis)
0%
Alkalosis (metabolic or respiratory)
0%
Cardiopulmonary arrest, cause unknown (non-fatal)
0%
Hemorrhage, GI::Anus
0%
Supraventricular and nodal arrhythmia::Atrial fibrillation
0%
Vomiting
0%
Arthritis (non-septic)
0%
Induration/fibrosis (skin and subcutaneous tissue)
0%
Cough
0%
Mucositis/stomatitis (clinical exam)::Oral cavity
0%
Infection with normal ANC or Grade 1 or 2 neutrophils::Heart (endocarditis)
0%
Infection ::Catheter-related
0%
Urinary frequency/urgency
0%
Metabolic/Laboratory - Other (pancytopenia; steroid induced hyperglycemia)
0%
Infection with unknown ANC::Wound
0%
Joint-function
0%
Myocarditis
0%
Psychosis (hallucinations/delusions)
0%
Renal/Genitourinary - Other (dysuria)
0%
Renal/Genitourinary - Other (insufficiency)
0%
Infection with normal ANC or Grade 1 or 2 neutrophils::Brain (encephalitis, infectious)
0%
Infection ::Trachea
0%
Infection with normal ANC or Grade 1 or 2 neutrophils::Esophagus
0%
Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)
0%
Infection with unknown ANC::Colon
0%
Urinary retention (including neurogenic bladder)
0%
Triglyceride, serum-high (hypertriglyceridemia)
0%
Weight loss
0%
Vaginal mucositis
0%
Cardiac General - Other (heart failure, fluid overload)
0%
Stricture/stenosis (including anastomotic), GI::Esophagus
0%
Hyperpigmentation
0%
Fistula, GI::Anus
0%
Glucose, serum-high (hyperglycemia)
0%
Infection with unknown ANC::Urinary tract NOS
0%
Fibrinogen
0%
Hemorrhage, GU::Bladder
0%
Infection ::Eye NOS
0%
Infection::Skin (cellulites)
0%
Infection::Urinary tract NOS
0%
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT00520130) in the B - Cyclosporine (AC) Arm ARM group. Side effects include: Lymphopenia with 60%, Neutrophils/granulocytes (ANC/AGC) with 60%, Rash/desquamation with 58%, Hemoglobin with 58%, Leukocytes (total WBC) with 58%.

Trial Design

3 Treatment Groups

Cocaine - Active (EFS)
1 of 3
Pilot
1 of 3
Cocaine - Sham (EFS)
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 170 total participants across 3 different treatment groups

This trial involves 3 different treatments. TMS is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Cocaine - Active (EFS)
Device
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.
Pilot
Device
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
Cocaine - Sham (EFS)
Device
To test the efficacy of the iTBS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TMS
2009
Completed Phase 2
~2280

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: each visit
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly each visit for reporting.

Closest Location

National Institute on Drug Abuse - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
justification: Many illnesses may affect both neural functioning and fMRI signals. show original
Screening tools: Medical Assessment, Medical History and Physical Examination. Medical assessments include: Vital Signs, EKG, oral HIV test, height/weight measurements, urinalysis, and blood sample. Tests on the blood sample include CBC, complete metabolic profile, TSH, ESR, syphilis test, and HIV (if needed to confirm a positive salivary test for HIV). The following individual laboratory results will independently disqualify individuals: Cholesterol >250 mg/dl, Hemoglobin < 10 g/dl, WBC < 2400/microliter, LFTs > 3 X upper normal limit, HCG positive, Casual serum glucose > 200 mg/dl, Urine protein > 1+, HIV positive. (Serum glucose over 140 mg/dl will be followed up with a fasting serum glucose assessment. Those with fasting glucose below 100 mg/dl may be considered for the protocol. Others will be rejected and referred for work-up.) Liver function will be evaluated with aspartate aminotransferase (AST) and alanine transaminase (ALT). A greater than 3 x upper normal limit for AST or ALT will disqualify individuals. MAI reserves the right to exclude at less extreme lab values if clinical judgment warrants exclusion.
To be able to give valid informed consent, you must be able to understand the information that is given to you show original
Be at least 18 years old and no more than 60 years old. show original
Age-related neural changes could cause variability in behavioral and MRI signals. show original
Screening tool: Self-report. Government-issued forms of identification (e.g. driver s license, birth certificate)
There are three right-handed people. show original
Different hemispheric dominance could interfere with the administration of iTBS and the measurements taken from MRI scans. show original
A tool used to measure handedness, the Edinburgh Handedness Inventory measures the strength of someone's preference for using their left or right hand. show original
Be fit and healthy. show original

Patient Q&A Section

Can cocaine abuse be cured?

"Drug abuse cannot be cured unless the addict is totally deprogrammed and stabilized at a place and in an environment that provides complete and permanent acceptance of his/her drug abuse problem and where the addict has regular contacts with a substance-abuse prevention and treatment team that he/she can continue to meet." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cocaine abuse?

"The prevalence of illicit drug use is increasing in the United States, and there is a great need to expand the scope of medical treatment for these challengers." - Anonymous Online Contributor

Unverified Answer

How many people get cocaine abuse a year in the United States?

"The American Cancer Society estimates that 30 to 150 thousand people in the United States get cocaine abuse a year; however, more research is needed on how many of these abusers later develop a problem." - Anonymous Online Contributor

Unverified Answer

What is cocaine abuse?

"Cocaine use has been increasing within the last decade, from 1.9% in 1996 to 11.5% in 2005 among 12- to 17-year-olds. This increase reflects an increase in recent acquisition and the continuing increase in use in established, long-term users." - Anonymous Online Contributor

Unverified Answer

What causes cocaine abuse?

"Different regions of the brain are affected differently by cocaine. Research suggests that cocaine is associated with the reward centers in the CNS and that some of these reward centers have also been implicated in addiction to other drugs including heroin. Data from a recent study of multiple studies, conducted in the past 15 years, show that drug addiction has multiple causes. Drug abuse is a complex process: individuals abuse drugs because it brings a feeling of euphoria but the true reasons for abusing drugs are complex and are not always understood. Addiction is a biological phenomenon caused by changes in the body's chemistry." - Anonymous Online Contributor

Unverified Answer

What are the signs of cocaine abuse?

"Signs of cocaine abuse often start with behavioral changes such as increased drinking and compulsive use patterns. Also, many signs appear during the withdrawal phase. However, some signs of cocaine abuse may not appear for up to a month after first use of cocaine. These include paranoia, anxiety disorder, mood swings, hallucinations, dysphoria as well as depression and increased thoughts of suicide." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cocaine abuse?

"The primary cause of cocaine abuse is the same as that of other drugs of abuse: a desire to self-induce euphoria and escape from boredom. Cocaine abuse must be recognized and treated as a medical health problem because of its prevalence and health consequences." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tms for therapeutic use?

"Although the exact mechanism is unknown, current data suggest that the current protocols for evaluating TMS outcomes are inadequate to detect the full spectrum of improvements in depression, pain, and other symptoms achieved by the current protocols. Given that TMS appears to be a safe and effective intervention for chronic pain and depression, the development of clinical trials should include measures that examine effects in these areas in addition to improving pain and depression because of the impact on functional status. The development of treatment regimens that increase safety and efficacy, especially for improving pain and depression, are crucial to improving our ability to improve the treatment of chronic pain and mental distress." - Anonymous Online Contributor

Unverified Answer

Is tms typically used in combination with any other treatments?

"A limited number of clinical trials have evaluated tm's in the combination regimen with ancillary treatments. In some cases, tm was combined with a stimulant drug and in one case with a neuroleptic drug. There is no evidence to indicate that tm added to any type of ancillary treatment will have a general benefits over one that has been used alone to treat an addiction." - Anonymous Online Contributor

Unverified Answer

How does tms work?

"In addition to its pharmacological action tanesterodine exerts significant antidepressant and anxiolytic activity in animal models. Further studies are required to explore possible antidepressant or anxiolytic indications in humans." - Anonymous Online Contributor

Unverified Answer

Is tms safe for people?

"Although safety is a prerequisite, Tms offers some advantages. The fact that the only side effect of Tms is headache has eliminated some concerns in the medical community. In summary, we believe Tms offers a good option for treatment of cocaine users who are unable to discontinue their use in accordance with the WHO treatment guidelines." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cocaine abuse?

"Current clinical trials may not provide the appropriate treatment for cocaine abusers. Clinicians, especially those working with cocaine abusers, should consider clinical trials when treatment is needed. [Power(https://www.withpower.com/d/cocaine-abuse-clinical-trials) makes it easy to compare clinical trial results to current research and help determine which clinical trial will yield the best treatment options in your situation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Cocaine Use Disorders by sharing your contact details with the study coordinator.