Effect of rTMS on brain factors in cocaine dependence

Effects of 5-Hz Repetitive Transcranial Magnetic Stimulation on Serum Brain Derived Neurotrophic Factor and Clinical Variables in Cocaine Use Disorder

This study is testing whether a type of brain stimulation can help people with cocaine addiction by reducing cravings and improving thinking skills.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente (Academic / other)
• Locations: 1 site (Mexico City, Tlalpan)
• Trial ID: NCT06189690 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of 5-Hz repetitive transcranial magnetic stimulation (rTMS) on serum brain-derived neurotrophic factor (BDNF), craving, and cognitive function in individuals with cocaine use disorder. It features a longitudinal design with a short-term double-blind placebo-controlled phase involving 20 rTMS sessions, followed by a long-term phase of maintenance therapy over 12 weeks. Participants will undergo clinical assessments and blood tests at three time points to evaluate changes in BDNF levels, craving, and cognitive performance. The study also includes a comparative group to measure outcomes during periods without cocaine consumption.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with cocaine use disorder who have been using cocaine for at least 12 months and meet specific inclusion criteria.

Not a fit: Patients with a personal or family history of neurological disorders or those with other substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for individuals struggling with cocaine dependence by reducing cravings and enhancing cognitive function.

How similar studies have performed: Previous studies using rTMS for cocaine dependence have shown promising results, indicating potential for success in this approach.

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.

Where this trial is running

Mexico City, Tlalpan

• Instituto Nacional de Psiquiatría Ramón de la Fuente M. — Mexico City, Tlalpan, Mexico (Recruiting)

Study contacts

• Study coordinator: Erik D. Morelos-Santana, Ph D. Candidate

Conditions Cocaine Dependence; Craving; BDNF; rTMS; DLPFC