Treatment With Transcranial Magnetic Stimulation for Cocaine Addiction: Clinical Response and Functional Connectivity.
TMS_COC_CONN
Effects of Transcranial Magnetic Stimulation on Functional Connectivity and Response to Treatment of Cocaine Dependent Patients
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to investigate the short and long term clinical and cognitive effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz frequencies on the left dorsolateral prefrontal cortex in cocaine dependent patients and to examine possible changes in brain structure and functional connectivity associated with this intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 2, 2020
June 1, 2020
3.7 years
December 2, 2016
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Cocaine Craving (CCQ)
The craving will be measured using a craving questionnaire for cocaine validated in Mexican population (Cocaine Craving Questionnaire or CCQ).
Baseline, 2 weeks, 3 months
Change in Cocaine Craving (VAS)
The craving will be measured using a 100 mm visual analogue scales (VAS).
Baseline, 2 weeks, 3 months
Change in Cocaine Urine Test
Frequency of cocaine use will be measured using reagent strips from Instant View drug screening (\> 300 ng/mL). Results are Positive or Negative.
Baseline, 2 weeks, 3 months
Secondary Outcomes (8)
Changes in Psychopathological Symptoms
Baseline, 2 weeks, 3 months
Changes in Depression
Baseline, 2 weeks, 3 months
Changes in Anxiety
Baseline, 2 weeks, 3 months
Changes in Drug Consumption and Related Problems
Baseline, 2 weeks, 3 months
Changes in Sleep Quality: PSQI
Baseline, 2 weeks, 3 months
- +3 more secondary outcomes
Study Arms (2)
Active rTMS frequency at 5 Hz
ACTIVE COMPARATORThe intervention will be Repetitive Transcranial Magnetic Stimulation. Each patient will receive treatment stimulation in the left dorsolateral prefrontal cortex (lDLPFC) with a frequency of 5 Hz, that includes 2 sessions per day for 10 consecutive business days for 2 weeks. Then a target frequency will be determined for the remaining of the study. If this arm's target frequency is chosen, then the participants will receive the maintenance intervention of 2 sessions per week for 12 months. Each session will consist of the application of rTMS at a frequency of 5Hz, to 100% of the motor threshold.
Sham rTMS frequency at 5 Hz
SHAM COMPARATORThe intervention will be Repetitive Transcranial Magnetic Stimulation (Sham). rTMS will be used with a coil that allows simulated stimulation (Coil AP) at a frequency of 5 Hz, with the software necessary for the operator to remain blind to the stimulation condition. This arm will only last for 2 weeks.
Interventions
The investigators will use a Magpro R-30 MagVenture quick stimulator, equipped with an 8-reel, 75 mm internal diameter in each spiral. Each patient will receive consistent treatment in 2 sessions a day for 10 consecutive business days in the first two weeks, then receive 2 weekly sessions, until the year of treatment is completed. Each session will consist of the application of 30 trains of 10 seconds duration separated by intervals of one minute, at a fixed frequency (5Hz or 10Hz), to 100% of the motor threshold.
The investigators will use a Magpro R-30 MagVenture quick stimulator, equipped with an 8-reel, 75 mm internal diameter in each spiral with a coil that allows simulated stimulation (Coil AP). This condition will only last two weeks.
Eligibility Criteria
You may qualify if:
- Minimum age of eighteen and maximum of fifty years.
- Cocaine users for at least 1 year, currently using at least 3 times a week, with abstinence periods continuing to be less than one month in the last year.
- The reading level of at least 6th grade of primary (equivalent to fifth grade of elementary school).
- The ability to give a valid informed consent.
- Right-handed (in order to control by cerebral laterality in Neuroimaging).
- If the subject is female and of childbearing age, she agrees to use a medically acceptable form of contraception, and to not become pregnant during the duration of the study. A woman is considered to have potential for pregnancy, unless she is postmenopause or surgically sterilized. Female patients of childbearing potential should use either: (1) contraceptive pill or hormone preparation IUD or deposit (ring, injection, implant); And / or (2) a barrier method of contraception, such as the diaphragm, spermicide sponge, or a condom.
- Contraceptive measures will be reviewed with the female subjects at each visit prior to the rTMS treatment.
- Self-report of experiencing cocaine craving when exposed to cocaine-associated cues.
- Body mass index less or equal to 30, allowing them to safely enter the Magnetic Resonance.
You may not qualify if:
- Personal or first-degree family history of any clinically defined neurological disorder, including organic brain disease, epilepsy, brain events, brain injury, or multiple sclerosis; Or personal history of previous neurosurgery or traumatic brain injury that have produced loss of consciousness.
- Cardiac pacemakers, neural stimulators, implantable defibrillators, implanted medication pumps, intracardiac lines, or acute, unstable heart disease, with intracranial implants (eg, aneurysm clips, leads, stimulators, cochlear implants, or electrodes) or with any other Metallic object inside or near the head that can not be safely removed.
- Screw metal or metallic projectiles into the head or body.
- Current use of any investigational drug or any anti-proconvulsant drug such as tricyclic or neuroleptic antidepressants (which reduce the seizure threshold).
- Increased intracranial pressure (decreasing seizure threshold).
- History of schizophrenia, bipolar disorder, mania or hypomania.
- History of myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, cerebrovascular events or transient ischemic attack, or any heart condition currently under medical care.
- Women with reproductive potential who do not use an acceptable form of contraception pregnant or who are lactating.
- Any history of seizures.
- The current dependence (DSM-V criteria) on substances other than cocaine and / or nicotine.
- Claustrophobia making them unable to tolerate lying inside the MRI scanner.
- History of HIV infection or HIV antibody test positive (Due to potential neuroinfection).
- These data will be corroborated by a screening visit where the following instruments will be used:
- Clinical Interview. Self-applicable demographic questionnaire. Mini International Neuropsychiatric Interview (MINI-Plus). Structured clinical interview for DSM Axis II, self report (SCID-II).
- Elimination criteria:
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Psiquiatría "Ramón de la Fuente Muñiz"
Mexico City, 14370, Mexico
Related Publications (1)
Garza-Villarreal EA, Alcala-Lozano R, Fernandez-Lozano S, Morelos-Santana E, Davalos A, Villicana V, Alcauter S, Castellanos FX, Gonzalez-Olvera JJ. Clinical and Functional Connectivity Outcomes of 5-Hz Repetitive Transcranial Magnetic Stimulation as an Add-on Treatment in Cocaine Use Disorder: A Double-Blind Randomized Controlled Trial. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Jul;6(7):745-757. doi: 10.1016/j.bpsc.2021.01.003. Epub 2021 Jan 26.
PMID: 33508499DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo A Garza-Villarreal, MD, PHD
Universidad Nacional Autonoma de Mexico
- PRINCIPAL INVESTIGATOR
Ruth Alcala-Lozano, MD, MSc
Instituto Nacional de Psiquiatria "Ramon de la Fuente Muñiz"
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 2, 2016
First Posted
December 8, 2016
Study Start
May 1, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
July 2, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
After the main publications by the group are released, all data (clinical, cognitive and neuroimaging) will be uploaded to an online open server such as LONI or OpenfMRI, for example.