Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02927236
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2016-10-06
Brief Title:
Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Neuroplasticity Following Theta-Burst Stimulation in Cocaine Use Disorder
Status:
COMPLETED
Status Verified Date:
2024-08-27
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
More effective treatments for people with cocaine use disorder are needed Researchers want to understand the parts of the brain involved in the disorder Transcranial magnetic stimulation TMS stimulates parts of the brain A form of TMS called intermittent theta-burst stimulation iTBS may help reduce cocaine use Researchers want to learn how the brain might change with treatment
Objectives
To test if iTBS can reduce cocaine use Also to learn how cocaine changes the heart and the brain
Eligibility
Healthy right-handed adults ages 18-60 who do or do not have cocaine use disorder
Design
Participants will be screened with
Questionnaires
Medical history
Physical exam
Blood and urine tests
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 A brief electrical current passes through the coil They view cocaine-related images during each session Sessions are videotaped
Repeat of screening tests
In the main study participants will be randomly assigned to have either real or fake iTBS
Participants with cocaine use disorder will join an incentive program to quit
Participants will have 39 visits over 6 months These include
Repeat of screening tests
MRIs at 5 visits Participants lie on a table that slides into a cylinder that takes pictures of the brain They respond to images while in the scanner
iTBS at 10 visits 5 days a week for 2 weeks
Participants will be contacted throughout the study to discuss iTBS treatment and drug use
More effective treatments for people with cocaine use disorder are needed Researchers want to understand the parts of the brain involved in the disorder Transcranial magnetic stimulation TMS stimulates parts of the brain A form of TMS called intermittent theta-burst stimulation iTBS may help reduce cocaine use Researchers want to learn how the brain might change with treatment
Objectives
To test if iTBS can reduce cocaine use Also to learn how cocaine changes the heart and the brain
Eligibility
Healthy right-handed adults ages 18-60 who do or do not have cocaine use disorder
Design
Participants will be screened with
Questionnaires
Medical history
Physical exam
Blood and urine tests
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 A brief electrical current passes through the coil They view cocaine-related images during each session Sessions are videotaped
Repeat of screening tests
In the main study participants will be randomly assigned to have either real or fake iTBS
Participants with cocaine use disorder will join an incentive program to quit
Participants will have 39 visits over 6 months These include
Repeat of screening tests
MRIs at 5 visits Participants lie on a table that slides into a cylinder that takes pictures of the brain They respond to images while in the scanner
iTBS at 10 visits 5 days a week for 2 weeks
Participants will be contacted throughout the study to discuss iTBS treatment and drug use
Detailed Description:
Objectives Illicit drug use affects tens of millions of Americans and costs nearly 200 billion annually in health care costs and lost productivity Cocaine dependence accounts for 25 of reported lifetime drug dependence though few successfully abstain with treatment For efforts toward positive long-term outcomes it is imperative to identify risk factors of poor outcomes specialized treatments neural mechanisms that change with treatment and predictive measures of treatment outcomes Substance abusers are known to have dysregulation in cue reactivity reward processing executive control and intrinsic network connectivity Non-invasive brain stimulation NIBS has proven effective at reducing drug craving in nicotine alcohol and cocaine users Here intermittent theta-burst stimulation iTBS a type of NIBS delivered to left dorsolateral prefrontal cortex dlPFC is implemented to modulate substance abuse related circuit dysregulations and assess the relationship of iTBS-induced changes in circuitry to ongoing cocaine use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-DA-N002 | None | None | None |