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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

rTMS
Device
Repetitive TMS will be administered by a MagPro R30 stimulator and an active/placebo MCF-B70 A/P coil. All participants will use two surface electrodes to simulate rTMS skin sensations near to stimulation site. rTMS/sham conditions will be double-blinded by a USB stick. The USB contains the information about rTMS/sham condition and this is not available to the stimulator operator. Parameters of rTMS were previously described.

Treatment groups

102 Participants

are divided into 3 treatment groups

Group A: rTMS 5 Hz groupExperimental treatment 1 intervention

Group B: Sham groupSham comparator 1 intervention

Group C: no rTMS control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

BDNF

Serum BDNF levels will be measured by an ELISA kit following the manufacturer's instructions.

Time frame

T0 before the intervention, T1: after rTMS 2 weeks, T2: after 12 weeks maintenance phase

Cocaine craving

The Cocaine Craving Questionnaire (CCQ) in the general and now versions will be used to measure craving. Additionally, the visual analog scale (VAS) to cocaine/crack desire consumption will be used as craving measurement.

Time frame

T0 before the intervention, T1: after rTMS 2 weeks, T2: after 12 weeks maintenance phase

Secondary outcomes

Depression

The 17-item Hamilton Depression Rating Scale (HAM-D) will be used,

Time frame

T0 before the intervention, T1: after rTMS 2 weeks, T2: after 12 weeks maintenance phase

Anxiety

The 14-item Hamilton Anxiety Rating Scale (HAM-A) will be used.

Time frame