Cocaine Dependence, Cocaine Use Disorder
Conditions
Keywords
Non-Invasive Brain Stimulation, Functional Magnetic Resonance Imaging (fMRI), intermittent theta burst stimulation (iTBS), transcranial magnetic stimulation (TMS)
Brief summary
Objective: The goal of this clinical trial is to assess the tolerability of an accelerated intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation, intervention in participants with cocaine use disorder and then to determine if the intervention changes brain circuits related to cocaine use disorder and whether these changes relate to clinical outcomes. The main questions it aims to answer are: * Can individuals with cocaine use disorder tolerate accelerated iTBS (3 treatments per day for 10 days) (Pilot study)? * Does iTBS (compared to sham iTBS) alter brain circuits related to cocaine use disorder (Expanded feasibility study)? Researchers will compare individuals with cocaine use disorder to those without cocaine use disorder to identify differences at baseline, compare effects of the first day of iTBS treatment, and see if changes after treatment align brain circuits in those with cocaine use disorder more closely to patterns seen in those without cocaine use disorder. Participants will: * Undergo 10 days of iTBS treatment and two follow-up visits (1 week and 4 weeks after treatment) and complete questionnaires throughout to assess tolerability and drug use (Pilot study). * Participants with cocaine use disorder will complete a characterization phase with questionnaires, two fMRI scans and a trial session of iTBS (sham or active) before the treatment phase (Expanded feasibility study).
Detailed description
Background and objective: The goal of this clinical trial is to assess the tolerability of an accelerated intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation, intervention in participants with cocaine use disorder and then to determine if the intervention changes brain circuits related to cocaine use disorder and whether these changes relate to clinical outcomes. The main questions it aims to answer are: * Can individuals with cocaine use disorder tolerate accelerated iTBS (3 treatments per day for 10 days) (Pilot study)? * Does iTBS (compared to sham iTBS) alter brain circuits related to cocaine use disorder (Expanded feasibility study)? Researchers will compare individuals with cocaine use disorder to those without cocaine use disorder to identify differences at baseline, compare effects of the first day of iTBS treatment, and see if changes after treatment align brain circuits in those with cocaine use disorder more closely to patterns seen in those without cocaine use disorder. Participants will: * Undergo 10 days of iTBS treatment and two follow-up visits (1 week and 4 weeks after treatment) and complete questionnaires throughout to assess tolerability and drug use (Pilot study). * Participants with cocaine use disorder will complete a characterization phase with questionnaires, two fMRI scans and a trial session of iTBS (sham or active) before the treatment phase (Expanded feasibility study). * Participants with cocaine use disorder will complete a treatment phase with questionnaires, urine drug testing, two fMRI scans before and after the first day of treatment, ten days with three iTBS treatments (sham or active) each day (Expanded feasibility study). * Participants with cocaine use disorder will complete a follow-up phase with contingency management for 11 weeks, follow-up fMRI scans 2 weeks and three months after the end of iTBS treatment and three monthly follow-up visits with urine drug testing and questionnaires after completion of the contingency management phase. * Participants without cocaine use disorder will complete the same characterization phase as those with cocaine use disorder but will not receive a full treatment course of iTBS. Instead, they will complete the first treatment day twice, once with active and once with sham iTBS. Study Population: Participants age 18 - 60 years of age (pilot study) and participants age 22 - 60 (Expanded Feasibility Study) Study Design: * Participants with cocaine dependence will receive open label iTBS in the pilot study * Participants with cocaine dependence will receive active or sham iTBS in double blinded experiment in the Expanded Feasibility Study (EFS) * Healthy Participants will complete the first treatment day twice and receive both active and sham iTBS treatment over two visits with at least five days between visits in a double blinded experiment
Interventions
DEVICETranscranial magnetic stimulation (TMS)
Theta burst stimulation is a type of TMS.To administer the iTBS treatment, a MagVenture MagPro 100 with MagOption (MagVenture Inc, Alpharetta, GA) machine equipped with a figure-8 active/sham coil will be used.
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Pilot study: open label; Expanded feasibility study: double blind, sham controlled
Intervention model description
Pilot study: single arm; Expanded feasibility study: parallel arm
Eligibility
Sex/Gender
ALL
Age
22 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* INCLUSION CRITERIA - PILOT PHASE: P1: 1. Be able to give valid informed consent. 2. Be 18 - 60 years of age. 3. Right-handed. 4. Be in good health. 5. Absence of a specific learning disability, attention deficit hyperactivity disorder (ADHD) or cognitive impairment 6. Participants will meet DSM-5 criteria for current moderate to severe substance (i.e., cocaine) use disorder, without a period of continuous abstinence lasting a one-month period over the last year, other than in a controlled environment.
Exclusion criteria
- PILOT PHASE: P1: 1. History of any neurological disorder that would increase seizure risk from iTBS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. 2. Current DSM-5 moderate-severe substance use disorder on a substance other than cocaine, nicotine, marijuana, or opiates (provided they are currently stable on Suboxone) or meeting withdrawal criteria for alcohol or a sedative/hypnotic/anxiolytic, or tolerance criteria in an individual using 3 or more days/week, regardless of diagnosis. Individuals will be considered stable on Suboxone if they have been on a stable dose for at least 2-weeks prior to consenting to 17-DA-N002 and have provided at least 3 urine specimens negative for illicit opioids over the same 2-week period (10 business days) with at least one test collected within two business days of the start of the period, one collected within three business days of the end of the period and one collected at least two days from either of the other two specimens. Urine results may be gathered at National Institute on Drug Abuse (NIDA) as part of screening or be provided by the Suboxone prescriber. Communication between the Suboxone provider and the MAI (or covering Staff Clinician) will be ongoing to establish continued illicit opioid abstinence between participant clearance and consent to 17-DA-N002. Individuals must be receiving their Suboxone as take-home doses from an external (i.e., non-NIDA-IRP) provider. 3. First-degree family history of any neurological disorder with a potentially hereditary basis, including migraines, epilepsy, or multiple sclerosis. 4. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes iTBS administration. 5. Noise-induced hearing loss or tinnitus. 6. Current use (any use in the past 4 weeks, daily use for more than a week within past 6 months) of any investigational drug or of any medications with psychotropic (e.g., benzodiazepines), anti or pro-convulsive action, or anti-coagulants. This will be determined at the discretion of the MAI. 7. Lifetime history of schizophrenia, bipolar disorder, mania, or hypomania. 8. 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. 9. Pregnant or lactating women or women with reproductive potential who engage in heterosexual sex that may lead to pregnancy and not using a medically acceptable form of contraception (such as birth control pills, condoms, or a diaphragm with spermicide). 10. Participation in any NIBS session (excluding the current protocol) less than two weeks ago. No NIBS exposure for treatment purposes in the last 6 months. INCLUSION CRITERIA - EXPANDED FEASIBILITY PHASE (EFS): 1. Be able to give valid informed consent. 2. Agree to also participate in study 10-DA-N457, where characterization information is gathered and shared with this protocol. 3. Be 22 - 60 years of age. 4. Right-handed. 5. Be in good health. 6. Absence of a specific learning disability, ADHD or cognitive impairment 7. Cocaine dependent (CD) participants, and not healthy control (HC) participants, will meet Diagnostic and Statistical Manual (DSM)-5 criteria for current moderate to severe substance (i.e., cocaine) use disorder, without a period of continuous abstinence lasting a one-month period over the last year, other than in a controlled environment and currently seeking treatment. They will be using at least once a week in the month prior to enrollment. 8. Treatment seeking CD participants 9. MRI compatible EXCLUSION -EFS 1. History of any neurological disorder that would increase seizure risk from iTBS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. 2. Current DSM-5 moderate-severe substance use disorder on a substance other than cocaine, nicotine, marijuana, or opiates (provided they are currently stable on a medication assisted treatment) or meeting withdrawal criteria for a sedative/hypnotic/anxiolytic, or tolerance criteria in an individual using 3 or more days/week, regardless of diagnosis. Individuals will be considered stable on a maintenance medication if they have been on a stable dose for at least 2-weeks prior to consenting to 17-DA-N002 and have provided at least 3 urine specimens negative for illicit opioids over the same 2-week period (10 business days) with at least one test collected within two business days of the start of the period, one collected within three business days of the end of the period and one collected at least two days from either of the other two specimens. Urine results may be gathered at NIDA as part of screening or be provided by the buprenorphine maintenance prescriber. Communication between the maintenance provider and the MAI (or covering Staff Clinician) will be ongoing to establish continued illicit opioid abstinence between participant clearance and consent to 17-DA-N002. 3. HC participants will not currently meet DSM-5 criteria for moderate to severe substance use disorder (excluding nicotine), and in the past, will not meet DSM-5 criteria for moderate to severe substance use disorder for cannabis or alcohol in the past 5 years or ever for other illicit substances. HC will not meet current withdrawal criteria for alcohol or sedative/hypnotics/anxiolytics, or tolerance criteria in an individual using 3 or more days/week. Urine toxicology positive for any illicit substance inconsistent with history given will also be exclusionary. 4. First-degree family history of any form of epilepsy with a potentially hereditary basis . 5. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes iTBS administration. 6. Noise-induced hearing loss or tinnitus. 7. Current use (any use in the past 4 weeks, daily use for more than a week within past 6 months) of any investigational drug or of any medications with psychotropic (e.g., benzodiazepines), anti or pro-convulsive action, or anti-coagulants. This will be determined at the discretion of the MAI. 8. Lifetime history of schizophrenia, bipolar disorder, mania, or hypomania. 9. Pregnant women or women with reproductive potential who engage in heterosexual sex that may lead to pregnancy and not using a medically acceptable form of contraception (such as birth control pills, condoms, or a diaphragm with spermicide). 10. Participation in any NIBS session less than two weeks prior to admission. No NIBS exposure for treatment purposes in the last 6 months. 11. Non-English speaking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cocaine Dependent Participants Who Tolerated Intermittent Theta-Burst Stimulation Sessions | Up to 10 days of treatment | Number of cocaine dependent participants who tolerated the intermittent Theta-Burst Stimulation (iTBS) treatment. Participants in the pilot group had a maximum of 2 weeks and participants in the EFS group had a maximum of three weeks to complete the 10 days of treatment. |
| Change in Brain Global Efficiency After Day One of Intermittent Theta-Burst Stimulation Treatment (Acute Effect) | pre/post treatment day 1. | Participants received resting brain fMRI scan followed by three iTBS sessions then a second brain fMRI scan. Analysis was done to determine if iTBS alters brain networks and calculated as the difference between global efficiency (GE) before and after the first day of iTBS (pre-post). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shortest pathway between each pair of nodes. The final value is 1/N(N-1) \* sum 1/shortest pathway between each pair of the N nodes. It ranges between 0 and 1 with higher values indicating greater efficiency. |
| Change in Brain Global Efficiency After Intermittent Theta-Burst Stimulation Treatment (iTBS) Course (Chronic Effect) | Baseline (pre-treatment) minus two weeks post treatment | Participants received baseline resting brain fMRI scan on day one and had a repeat brain fMRI two weeks after iTBS treatment course. Analysis was done to determine change in brain network with chronic treatment in cocaine dependent participants and calculated as the difference between global efficiency (GE) from baseline to post treatment (2 weeks after end of treatment). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shortest pathway between each pair of nodes. The final value is 1/N(N-1) \* sum 1/shortest pathway between each pair of the N nodes. It ranges between 0 and 1 with higher values indicating greater efficiency. |
| Brain Global Efficiency Before Intermittent Theta-Burst Stimulation Treatment (iTBS) | Baseline (pre-treatment) | The brain global efficiency for cocaine dependent participants and healthy control participants at baseline (pre-treatment), prior to intermittent Theta-Burst Stimulation Treatment (iTBS). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shortest pathway between each pair of nodes. The final value is 1/N(N-1) \* sum 1/shortest pathway between each pair of the N nodes. It ranges between 0 and 1 with higher values indicating greater efficiency. |
Countries
United States
Participant flow
Pre-assignment details
Pilot Phase: participants complete a characterization phase prior to the treatment phase and do not proceed to the treatment phase unless they tolerate a brief trial of intermittent Theta-Burst Stimulation (iTBS) Expanded Feasibility Study (EFS) Phase: participants complete a characterization phase and do not proceed to the treatment phase unless they tolerate a brief trial of iTBS and score in the unimpaired range on Trails B, used to assess for cognitive impairment after receiving iTBS
Participants by arm
| Arm | Count |
|---|---|
| Pilot Group Participants with cocaine dependence receive open label three daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions for up to 10 days. | 19 |
| Expanded Feasibility Study (EFS): Cocaine - Active Group Participants with cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans. | 4 |
| Expanded Feasibility Study (EFS): Cocaine - Sham Group Participants with cocaine dependence receive three sham daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans. | 3 |
| Expanded Feasibility Study (EFS): Healthy Control Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double blind experiment in one day and three sham daily iTBS sessions with an inter-administration interval of at least 60-minutes between sessions in a double blind experiment in one day with at least five days between the active and sham treatment. | 19 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Characterization Phase | Lost to Follow-up | 0 | 0 | 0 | 3 |
| Characterization Phase | Physician Decision | 0 | 3 | 0 | 2 |
| Characterization Phase | Withdrawal by Subject | 1 | 0 | 0 | 1 |
| Follow-up Phase | Lost to Follow-up | 1 | 0 | 1 | 0 |
| Treatment Phase | Adverse Event | 1 | 0 | 1 | 1 |
| Treatment Phase | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Treatment Phase | Protocol Violation | 3 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Expanded Feasibility Study (EFS): Cocaine - Active Group | Expanded Feasibility Study (EFS): Cocaine - Sham Group | Expanded Feasibility Study (EFS): Healthy Control | Pilot Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 3 Participants | 19 Participants | 19 Participants | 45 Participants |
| Age, Continuous | 50.25 years STANDARD_DEVIATION 11.15 | 42 years STANDARD_DEVIATION 8.89 | 35.7 years STANDARD_DEVIATION 9.23 | 47.5 years STANDARD_DEVIATION 8.6 | 42.26 years STANDARD_DEVIATION 10.68 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 8 Participants | 14 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 6 Participants | 3 Participants | 13 Participants |
| Region of Enrollment United States | 4 participants | 3 participants | 19 participants | 19 participants | 45 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 6 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 13 Participants | 13 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 4 | 0 / 3 | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 10 / 19 | 0 / 4 | 2 / 3 | 2 / 19 | 3 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 4 | 0 / 3 | 0 / 19 | 0 / 19 |
Outcome results
Primary
Brain Global Efficiency Before Intermittent Theta-Burst Stimulation Treatment (iTBS)
The brain global efficiency for cocaine dependent participants and healthy control participants at baseline (pre-treatment), prior to intermittent Theta-Burst Stimulation Treatment (iTBS). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shortest pathway between each pair of nodes. The final value is 1/N(N-1) \* sum 1/shortest pathway between each pair of the N nodes. It ranges between 0 and 1 with higher values indicating greater efficiency.
Time frame: Baseline (pre-treatment)
Population: Analysis included all cocaine dependent participants (combined as one group as no intermittent Theta-Burst Stimulation (iTBS) sessions had been administered at this timepoint) and healthy control participants who had a baseline brain fMRI scan. No baseline scan was done on Pilot participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Group | Brain Global Efficiency Before Intermittent Theta-Burst Stimulation Treatment (iTBS) | 0.370168044 unitless | Standard Deviation 0.070814395 |
| Expanded Feasibility Study (EFS): Cocaine - Active Group | Brain Global Efficiency Before Intermittent Theta-Burst Stimulation Treatment (iTBS) | 0.328063781 unitless | Standard Deviation 0.035358035 |
Primary
Change in Brain Global Efficiency After Day One of Intermittent Theta-Burst Stimulation Treatment (Acute Effect)
Participants received resting brain fMRI scan followed by three iTBS sessions then a second brain fMRI scan. Analysis was done to determine if iTBS alters brain networks and calculated as the difference between global efficiency (GE) before and after the first day of iTBS (pre-post). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shortest pathway between each pair of nodes. The final value is 1/N(N-1) \* sum 1/shortest pathway between each pair of the N nodes. It ranges between 0 and 1 with higher values indicating greater efficiency.
Time frame: pre/post treatment day 1.
Population: The analysis was between-subjects for cocaine dependent participants and within-subjects for healthy participants. No imaging data was collected for the Pilot arm so no results are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Group | Change in Brain Global Efficiency After Day One of Intermittent Theta-Burst Stimulation Treatment (Acute Effect) | -0.03716097 unitless | Standard Deviation 0 |
| Expanded Feasibility Study (EFS): Cocaine - Active Group | Change in Brain Global Efficiency After Day One of Intermittent Theta-Burst Stimulation Treatment (Acute Effect) | 0.004610517 unitless | Standard Deviation 0.003557275 |
| Expanded Feasibility Study (EFS): Healthy Control - Active Treatment | Change in Brain Global Efficiency After Day One of Intermittent Theta-Burst Stimulation Treatment (Acute Effect) | -.01535 unitless | Standard Deviation 0.032982662 |
| Expanded Feasibility Study (EFS): Healthy Control - Sham Treatment | Change in Brain Global Efficiency After Day One of Intermittent Theta-Burst Stimulation Treatment (Acute Effect) | -0.008708172 unitless | Standard Deviation 0.021423157 |
Primary
Change in Brain Global Efficiency After Intermittent Theta-Burst Stimulation Treatment (iTBS) Course (Chronic Effect)
Participants received baseline resting brain fMRI scan on day one and had a repeat brain fMRI two weeks after iTBS treatment course. Analysis was done to determine change in brain network with chronic treatment in cocaine dependent participants and calculated as the difference between global efficiency (GE) from baseline to post treatment (2 weeks after end of treatment). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shortest pathway between each pair of nodes. The final value is 1/N(N-1) \* sum 1/shortest pathway between each pair of the N nodes. It ranges between 0 and 1 with higher values indicating greater efficiency.
Time frame: Baseline (pre-treatment) minus two weeks post treatment
Population: Analysis included only cocaine dependent participants in the Expanded Feasibility Study (EFS) arms who completed the baseline and follow up fMRI brain scans. Chronic effects of iTBS were not measured in the Pilot or in EFS healthy participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Group | Change in Brain Global Efficiency After Intermittent Theta-Burst Stimulation Treatment (iTBS) Course (Chronic Effect) | -0.009259302 unitless | Standard Deviation 0 |
| Expanded Feasibility Study (EFS): Cocaine - Active Group | Change in Brain Global Efficiency After Intermittent Theta-Burst Stimulation Treatment (iTBS) Course (Chronic Effect) | -0.021988865 unitless | Standard Deviation 0.009881832 |
Primary
Number of Cocaine Dependent Participants Who Tolerated Intermittent Theta-Burst Stimulation Sessions
Number of cocaine dependent participants who tolerated the intermittent Theta-Burst Stimulation (iTBS) treatment. Participants in the pilot group had a maximum of 2 weeks and participants in the EFS group had a maximum of three weeks to complete the 10 days of treatment.
Time frame: Up to 10 days of treatment
Population: Per protocol document, analysis applies to only participants who had cocaine dependence.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Group | Number of Cocaine Dependent Participants Who Tolerated Intermittent Theta-Burst Stimulation Sessions | 9 Participants |
| Expanded Feasibility Study (EFS): Cocaine - Active Group | Number of Cocaine Dependent Participants Who Tolerated Intermittent Theta-Burst Stimulation Sessions | 1 Participants |