Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03333460
Status:
UNKNOWN
Last Update Posted:
2017-11-07
First Post:
2017-09-21
Brief Title:
Transcranial Magnetic Stimulation for Cocaine Addiction
Sponsor:
ITAB - Institute for Advanced Biomedical Technologies
Organization:
ITAB - Institute for Advanced Biomedical Technologies
Study Overview
Official Title:
Cracking Addiction Does BRAIN Stimulation-induced Neuroplasticity Reverse Prefrontal Cortex Hypoactivity in Cocaine and neW stImulanTs addiCtion in Humans BRAIN SWITCH
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
RECRUITING
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:
BRAINSWITCH
Brief Summary:
Background Cocaine use disorders CUD is a complex brain disorder involving several brain areas and neurocircuits Effective treatments for CUD are still needed Repetitive transcranial magnetic stimulation rTMS stimulates non-invasively parts of the brain Preliminary data suggest that rTMS may help reducing cocaine craving and consumption Researchers want to learn how the brain and the drug-seeking behavior may change with this treatment
Objectives To test if rTMS can reduce cocaine craving and use and also affect several mood behavioral and cognitive alterations associated with prolonged cocaine use
Eligibility Healthy right-handed adults ages 18-65 who do have cocaine use disorder moderate to severe
Design This is a randomized double-blind sham-controlled study The study includes three phases 1 a rTMS continued treatment phase a rTMS follow-up and a no rTMS follow-up
Prior to participating participants will be screened with
Questionnaires
Medical history
Physical exam
Urine tests
MRI structural
After being enrolled baseline behavioral and imaging data will be collected In particular participants will undergo
Questionnaires
Functional MRI
During the continued rTMS phase participants with cocaine use disorder will be randomized to receive real or fake rTMS Repetitive TMS will be delivered during 10 outpatient treatment days over 2 weeks 5 daysweek Following this phase subjects will have 12 follow-up visits onceweekly during which they will receive rTMS and behavioral and imaging assessments will be performed At the end of the rTMS follow up period participants will further receive 3 follow up visits once a month during which rTMS will not be performed but behavioral data will be collected
Treatment includes
rTMS A coil is placed on the head A brief electrical current passes through the coil At each visit participants will receive two rTMS sessions with a 1hr interval between sessions At the beginning of each rTMS session they view cocaine-related images for few minutes
MRIs at baseline and at follow-up visit 12 Participants lie on a table that slides into a cylinder that takes pictures of the brain They respond to images while in the scanner
Repeat of screening tests and questionnaires
Urine toxicological screen
Objectives To test if rTMS can reduce cocaine craving and use and also affect several mood behavioral and cognitive alterations associated with prolonged cocaine use
Eligibility Healthy right-handed adults ages 18-65 who do have cocaine use disorder moderate to severe
Design This is a randomized double-blind sham-controlled study The study includes three phases 1 a rTMS continued treatment phase a rTMS follow-up and a no rTMS follow-up
Prior to participating participants will be screened with
Questionnaires
Medical history
Physical exam
Urine tests
MRI structural
After being enrolled baseline behavioral and imaging data will be collected In particular participants will undergo
Questionnaires
Functional MRI
During the continued rTMS phase participants with cocaine use disorder will be randomized to receive real or fake rTMS Repetitive TMS will be delivered during 10 outpatient treatment days over 2 weeks 5 daysweek Following this phase subjects will have 12 follow-up visits onceweekly during which they will receive rTMS and behavioral and imaging assessments will be performed At the end of the rTMS follow up period participants will further receive 3 follow up visits once a month during which rTMS will not be performed but behavioral data will be collected
Treatment includes
rTMS A coil is placed on the head A brief electrical current passes through the coil At each visit participants will receive two rTMS sessions with a 1hr interval between sessions At the beginning of each rTMS session they view cocaine-related images for few minutes
MRIs at baseline and at follow-up visit 12 Participants lie on a table that slides into a cylinder that takes pictures of the brain They respond to images while in the scanner
Repeat of screening tests and questionnaires
Urine toxicological screen
Detailed Description:
Repetitive transcranial magnetic stimulation rTMS has been shown to reduce craving in cocaine addicts However the efficacy of rTMS in treating cocaine addiction has not been evaluated in double-blind sham-controlled studies and also we lack a full characterization of rTMS effects on other important aspects including effects on mood cognition and changes in brain function The purpose of this study is to investigate the effects of repetitive Transcranial Magnetic Stimulation rTMS at 15 Hz frequency on the left dorsolateral prefrontal cortex in cocaine dependent patients and to examine possible changes in mood cognition and brain activity and functional connectivity associated with this intervention For this purpose the investigators will recruit cocaine dependent patients After screening and informed consent participants will undergo active or sham rTMS for two consecutive weeks twice a day during the continued treatment phase and a maintenance intervention twice a week for 3 months during the rTMs follow-up phase Following this phase participants will be followed for further 3 months during which no rTMS will be delivered but clinical and imaging data will be collected The investigators will also measure clinical cognitive and brain structural and functional connectivity to assess changes related to the intervention in the short and long term measurements at baseline 2 weeks 3 months 6 months
Procedure The project consists of Screening Visit baseline Part 1 continued treatment phase Part 2 3 months- rTMS follow-up Part 3 3 months follow-up without rTMS First there will be a screening visit where a clinical interview will be conducted and questionnaires and tests will be administered to identify study participants who meet the inclusion and exclusion criteria Baseline clinical cognitive and neuroimaging data will be acquired The neuroimaging data will be exploratory to be associated with the outcome measures In Part 1 all participants will be randomly assigned to one of the two treatment arms with rTMS 15Hz 15Hz-Sham Participants will receive 2 sessions of rTMS active or sham twice per day for 10 consecutive days for a total of 20 rTMS sessions Following this the investigators will evaluate the acute effect of treatment on cocaine craving and consumption mood and cognition Also they will collect exploratory neuroimaging data functional MRI and resting state functional connectivity In Part 2 of the study all participants will continue the assigned treatment arm with rTMS 15Hz 15Hz-Sham for three months Participants will receive 2 sessions of rTMS active or sham once per week clinical and cognitive data will be acquired once per month The investigators will evaluate the effect of treatment on cocaine craving and consumption mood and cognition Also they will collect exploratory neuroimaging data functional MRI and resting state functional connectivity In Part 3 of the study participants will not receive any rTMS session Clinical and cognitive data will be acquired once per month for three months The investigators will evaluate the long-term effect of treatment on cocaine craving and consumption mood and cognition
Procedure The project consists of Screening Visit baseline Part 1 continued treatment phase Part 2 3 months- rTMS follow-up Part 3 3 months follow-up without rTMS First there will be a screening visit where a clinical interview will be conducted and questionnaires and tests will be administered to identify study participants who meet the inclusion and exclusion criteria Baseline clinical cognitive and neuroimaging data will be acquired The neuroimaging data will be exploratory to be associated with the outcome measures In Part 1 all participants will be randomly assigned to one of the two treatment arms with rTMS 15Hz 15Hz-Sham Participants will receive 2 sessions of rTMS active or sham twice per day for 10 consecutive days for a total of 20 rTMS sessions Following this the investigators will evaluate the acute effect of treatment on cocaine craving and consumption mood and cognition Also they will collect exploratory neuroimaging data functional MRI and resting state functional connectivity In Part 2 of the study all participants will continue the assigned treatment arm with rTMS 15Hz 15Hz-Sham for three months Participants will receive 2 sessions of rTMS active or sham once per week clinical and cognitive data will be acquired once per month The investigators will evaluate the effect of treatment on cocaine craving and consumption mood and cognition Also they will collect exploratory neuroimaging data functional MRI and resting state functional connectivity In Part 3 of the study participants will not receive any rTMS session Clinical and cognitive data will be acquired once per month for three months The investigators will evaluate the long-term effect of treatment on cocaine craving and consumption mood and cognition
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