Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder
ConditionCocaine Dependence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorInstituto Nacional de Psiquiatría Dr. Ramón de la Fuente
About this trial
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
Qualifiers
Current cocaine use disorder according to the Diagnostic and statistical manual of mental disorders (DSM 5).
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.
Primary school completed.
Disqualifiers
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.
Personal history of brain surgery or traumatic brain injury.
Comorbilities that could represent a risk of neuroinfection or increased convulsive threshoid.
Other than alcohol, tobacco or marijuana substance use disorder.
Trial design
Treatments tested in this trial
- rTMS
Treatment groups
102 Participants
are divided into 3 treatment groupsSponsors and collaborators
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Lead sponsor
National Council of Science and Technology, Mexico
Collaborator
Source ClinicalTrials.gov