Cocaine-Related DisordersTMS_COC_CONNNCT02986438
Treatment With Transcranial Magnetic Stimulation for Cocaine Addiction: Clinical Response and Functional Connectivity.
A study testing Repetitive Transcranial Magnetic Stimulation in people with Cocaine-Related Disorders, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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:
- The participation of all participants during the study will be suspended if:
- They express their desire to stop participating.
- They present abnormal radiological findings that require more attention outside the study to ensure the health of the participant.
- Worsening of clinical condition.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Psiquiatría "Ramón de la Fuente Muñiz"
Mexico City, 14370
Ruth Alcala, MD, MSc, +52(55)41605065, ruthalcala_@hotmail.com
About this study
Official title: Effects of Transcranial Magnetic Stimulation on Functional Connectivity and Response to Treatment of Cocaine Dependent Patients
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.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce craving in cocaine addicts in the short term. However, there are no studies on the long term clinical and cognitive effects of sustained rTMS therapy. Moreover, clinical improvement or decline could be related to long term changes in brain structure and function. 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. For this purpose the investigators will recruit cocaine dependent patients and stimulate them using rTMS with a acute intervention (twice a day for 2 weeks) and a maintenance intervention (twice a week for 3 months). The investigators will follow the patients to determine clinical outcome. The investigators will also measure clinical, cognitive and brain structural and functional connectivity to asses changes related to the intervention in the short and long term (measurements at: baseline, 2 weeks and 3 months).
Procedure:
The projects consists of: Screening Visit, Part 1 and Part 2.
First, there will be a screening visit, where a clinical interview will be conducted and tests will be applied to select study participants who meet the inclusion and exclusion criteria.
Baseline clinical, cognitive and neuroimaging data will be acquired. The cognitive and neuroimaging data will be exploratory, to be associated with the outcome measures. Part 1 of the study entails the determination of the rTMS target frequency (5 or 10 Hz) for Part 2 (long term stimulation). In Part 1, all participants will be randomly assigned to one of the four treatment legs with rTMS (10Hz, 10Hz-Sham, 5Hz, 5Hz-Sham). Participants will receive 20 sessions of rTMS (intervention or sham), twice per day for 10 consecutive days. Each session lasts approximately 35 minutes.
At 2 weeks, the investigators will evaluate the short term effect of treatment by measuring clinical, cognitive and neuroimaging changes and select which frequency of stimulation is the most effective in terms of clinical improvement, but also in terms of the rate of secondary effects. Our hypothesis is that 5 Hz is as effective as 10 Hz without the high rate of secondary effects (i.e. seizures).
In Part 2 of the study, the sham groups will end and they will be invited to the treatment condition although they data not will be considered for later phases. Here the maintenance phase starts (long term), where rTMS will be performed twice a week for 12 months using the target frequency (5 or 10 Hz). Clinical, cognitive and neuroimaging data will be acquired at 2 weeks and 3 months.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation (Sham)
- Keywords
- Cocaine, Addiction, rTMS, fMRI
- Medical subject headings
- Cocaine-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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.
Repetitive Transcranial Magnetic Stimulation (Sham)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS frequency at 5 Hz | Active comparator | The 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Sham rTMS frequency at 5 Hz | Sham comparator | The 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 2 weeks, 3 months
Change in Cocaine Craving (VAS)
The craving will be measured using a 100 mm visual analogue scales (VAS).
Measured: 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.
Measured: Baseline, 2 weeks, 3 months
Secondary outcomes (8)
Changes in Psychopathological Symptoms
Measured by the 90 Symptoms Questionnaire (SCL-90).
Measured: Baseline, 2 weeks, 3 months
Changes in Depression
Measured by Hamilton Depression Rating Scale (HDRS) (21 items).
Measured: Baseline, 2 weeks, 3 months
Changes in Anxiety
Measured by Hamilton Anxiety Rating Scale (HARS).
Measured: Baseline, 2 weeks, 3 months
Changes in Drug Consumption and Related Problems
Measured by the Addiction Severity Index (ASI-lite).
Measured: Baseline, 2 weeks, 3 months
Changes in Sleep Quality: PSQI
Measured by the Pittsburgh Sleep Quality Index (PSQI).
Measured: Baseline, 2 weeks, 3 months
Changes in Impulsivity
Measured by the Barrat Impulsivity Scale-11 (BIS-11).
Measured: Baseline, 2 weeks, 3 months
Lapse rate
Lapse is defined as at least one consumption event not in the same pattern as the baseline consumption. The report of self-consumption of cocaine and urine drug tests, with special attention to the presence of traces of cocaine.
Measured: Baseline, 2 weeks, 3 months
Relapse rate
Relapse is defined as consumption events in the same pattern as the baseline consumption. The report of self-consumption of cocaine and urine drug tests, with special attention to the presence of traces of cocaine.
Measured: Baseline, 2 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start1 May 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Jorge J. González Olvera, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Investigators
- Eduardo A Garza-Villarreal, MD, PHD, Principal investigator, Universidad Nacional Autonoma de MexicoRuth Alcala-Lozano, MD, MSc, Principal investigator, Instituto Nacional de Psiquiatria "Ramon de la Fuente Muñiz"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986438
- Sponsor's protocol ID
- IC16036.0
- Acronym
- TMS_COC_CONN
- Status last verified
- Jun 2020
- First submitted
- 2 Dec 2016
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Han Z, Liu T, Wang K, Yang G, Yan T. Structural connectome architecture and biological vulnerability shape cortical atrophy in cocaine use disorder. BMC Med. 2026 May 9;24(1):374. doi: 10.1186/s12916-026-04903-y.
PubMed 42106690Garza-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.
PubMed 33508499
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Magnetic Stimulation on Functional Connectivity and Response to Treatment of Cocaine Dependent Patients
- ClinicalTrials.gov ID
- NCT02986438
- Acronym / sponsor ID
- TMS_COC_CONN / IC16036.0
- Conditions
- Cocaine-Related Disorders
- Keywords
- Cocaine, Addiction, rTMS, fMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce craving in cocaine addicts in the short term. However, there are no studies on the long term clinical and cognitive effects of sustained rTMS therapy. Moreover, clinical improvement or decline could be related to long term changes in brain structure and function. 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. For this purpose the investigators will recruit cocaine dependent patients and stimulate them using rTMS with a acute intervention (twice a day for 2 weeks) and a maintenance intervention (twice a week for 3 months). The investigators will follow the patients to determine clinical outcome. The investigators will also measure clinical, cognitive and brain structural and functional connectivity to asses changes related to the intervention in the short and long term (measurements at: baseline, 2 weeks and 3 months).
Procedure:
The projects consists of: Screening Visit, Part 1 and Part 2.
First, there will be a screening visit, where a clinical interview will be conducted and tests will be applied to select study participants who meet the inclusion and exclusion criteria.
Baseline clinical, cognitive and neuroimaging data will be acquired. The cognitive and neuroimaging data will be exploratory, to be associated with the outcome measures. Part 1 of the study entails the determination of the rTMS target frequency (5 or 10 Hz) for Part 2 (long term stimulation). In Part 1, all participants will be randomly assigned to one of the four treatment legs with rTMS (10Hz, 10Hz-Sham, 5Hz, 5Hz-Sham). Participants will receive 20 sessions of rTMS (intervention or sham), twice per day for 10 consecutive days. Each session lasts approximately 35 minutes.
At 2 weeks, the investigators will evaluate the short term effect of treatment by measuring clinical, cognitive and neuroimaging changes and select which frequency of stimulation is the most effective in terms of clinical improvement, but also in terms of the rate of secondary effects. Our hypothesis is that 5 Hz is as effective as 10 Hz without the high rate of secondary effects (i.e. seizures).
In Part 2 of the study, the sham groups will end and they will be invited to the treatment condition although they data not will be considered for later phases. Here the maintenance phase starts (long term), where rTMS will be performed twice a week for 12 months using the target frequency (5 or 10 Hz). Clinical, cognitive and neuroimaging data will be acquired at 2 weeks and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Active rTMS frequency at 5 Hz | Active comparator | Device: Repetitive Transcranial Magnetic StimulationThe 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 comparator | Device: Repetitive Transcranial Magnetic Stimulation (Sham)The 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationThe 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. | Device | Active rTMS frequency at 5 Hz |
| Repetitive Transcranial Magnetic Stimulation (Sham)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. | Device | Sham rTMS frequency at 5 Hz |
Primary outcome
Change in Cocaine Craving (CCQ)
Time frame: Baseline, 2 weeks, 3 months
The craving will be measured using a craving questionnaire for cocaine validated in Mexican population (Cocaine Craving Questionnaire or CCQ).
Change in Cocaine Craving (VAS)
Time frame: Baseline, 2 weeks, 3 months
The craving will be measured using a 100 mm visual analogue scales (VAS).
Change in Cocaine Urine Test
Time frame: Baseline, 2 weeks, 3 months
Frequency of cocaine use will be measured using reagent strips from Instant View drug screening (> 300 ng/mL). Results are Positive or Negative.
8 secondary outcomes
Changes in Psychopathological Symptoms
Time frame: Baseline, 2 weeks, 3 months
Changes in Depression
Time frame: Baseline, 2 weeks, 3 months
Changes in Anxiety
Time frame: Baseline, 2 weeks, 3 months
Changes in Drug Consumption and Related Problems
Time frame: Baseline, 2 weeks, 3 months
Changes in Sleep Quality: PSQI
Time frame: Baseline, 2 weeks, 3 months
Changes in Impulsivity
Time frame: Baseline, 2 weeks, 3 months
Lapse rate
Time frame: Baseline, 2 weeks, 3 months
Relapse rate
Time frame: Baseline, 2 weeks, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Derived from this study: PubMed 42106690Han Z, Liu T, Wang K, Yang G, Yan T. Structural connectome architecture and biological vulnerability shape cortical atrophy in cocaine use disorder. BMC Med. 2026 May 9;24(1):374. doi: 10.1186/s12916-026-04903-y.
- Derived from this study: PubMed 33508499Garza-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo A Garza-Villarreal, MD, PHD principal investigator
Universidad Nacional Autonoma de Mexico
Ruth Alcala-Lozano, MD, MSc principal investigator
Instituto Nacional de Psiquiatria "Ramon de la Fuente Muñiz"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Cocaine-Related Disorders, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth Alcala-Lozano, MD, MSc (+52(55)41605065, ruthalcala_@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cocaine Craving (CCQ) (time frame: Baseline, 2 weeks, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.