NCT06189690 Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder
| NCT ID | NCT06189690 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente |
| Condition | Cocaine Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2022-01-06 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2022-01-06 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to explore the effect of 5-Hz rTMS over the left dorsolateral prefrontal cortex on the BDNF, craving and cognitive function. This study will be longitudinal, with a short-term double-blind placebo-controlled phase consisting of 20 rTMS sessions and a long-term phase, consisting of 2 weekly sessions for 12 weeks. Participants will be clinically assessed pre-treatment (T0), after 20-sessions phase (T1) and after 12-weeks phase (T2) by an interview about psychiatric symptoms. Also, blood will be obtained in the same T0, T1 and T2 to peripheral levels of BDNF determination. Cognitive state will be measured at the same time-points (T0, T1, T2) by paper-pencil and computerized neuropsychological assessment. Researchers will compare active rTMS versus placebo 5 Hz-rTMS on described variables. Additionally, a comparative group (without rTMS intervention) will be included to equivalently measure described variables during periods without cocaine consumption.
Eligibility Criteria
Inclusion Criteria: 1. Current cocaine use disorder according to the Diagnostic and statistical manual of mental disorders (DSM 5). 2. Cocaine crack or powder use for at least 12 months with a frequency of 3 times or more per week, with abstinence periods shorter than 1 year for the last year. 3. Primary school completed. Exclusion Criteria: 1. Personal or first degree family history of any neurological disorder including, but not limited to, organic brain syndrome, epilepsy, brain injuries, multiple sclerosis, conditions that increase intracranial pressure. 2. Personal history of brain surgery or traumatic brain injury. 3. Comorbilities that could represent a risk of neuroinfection or increased convulsive threshoid. 4. Other than alcohol, tobacco or marijuana substance use disorder. 5. If the patient does not meet the safety criteria for rTMS. 6. Current use of any medication that might provoque seizures or any anticonvulsant drugs. 7. Personal history of schizophrenia, mania/hypomania or OCD. 8. Personal history of myocardial infarction, angina, congestive heart failure, cerebrovascular events, transient ischemic attack or any other heart condition currently undergoing medical treatment. 9. Personal history of seizures or detection of paroxysmal EEG activity.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06189690 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Cocaine Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06189690 currently recruiting?
Yes, NCT06189690 is actively recruiting participants. Contact the research team at emorelos@imp.edu.mx for enrollment information.
Where is the NCT06189690 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT06189690 clinical trial?
NCT06189690 is sponsored by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente. The trial plans to enroll 102 participants.