An interventional study of rTMS in Cocaine Dependence, sponsored by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente · Not applicable, Interventional, and Treatment
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.
Brain derived neurotrophic factor (BDNF) is a widely explored neurotrophin in preclinical models of cocaine addiction with relevant phase and region dependent dynamics along addictive cycle. In humans with cocaine use disorder (CUD), peripheral BDNF have revealed relationship with relevant treatment outcomes as relapse and time of abstinence. In CUD several interventional studies using high frequency repetititve transcranial magnetic stimulation (rTMS) have shown craving reduction, mood improvements and sustained modifications in functional conectivity measued by fMRI. Due to the relevance of BDNF in CUD, and neuroplasticity-related processes derived from rTMS interventions, this study aims to determine changes in peripheral BDNF, craving, cognition in CUD in reponse to rTMS. Aditionally, other outcomes will be considered as depression, anxiety and motivational changes.
Procedure: Psychiatric clinical and cognitive assessment, and blood collection will be performed at T0, T1 and T2 time-points. Short-term rTMS phase will consist of two weeks (weekdays) with 2 rTMS or rTMS-placebo sessions (detaills in arms section). Then, two sessions per week along 12 weeks as maintenance therapy will be considered. No rTMS group will attend the same time points and assessment in a controlled facility.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's planned enrollment of 102 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two-session/day 5-Hz rTMS will be administered by two week (weekdays) with a 30-minutes inter-session interval. A total of 20 sessions will be administered. Then two sessions per week along 12 weeks will be administered as maintenance phase. Parameters are considered as follow: 10 s. train, 10 s. inter-train interval, 2500 pulses per session at 100% of motor threshold (MT).
Device: rTMS
Two-session/day sham 5-Hz rTMS will be administered by two week (weekdays) with a 30-minutes inter-session interval. A total of 20 sessions will be administered. Then two sessions per week along 12 weeks will be administered as maintenance phase. Parameters are considered as follow: 10 s. train, 10 s. inter-train interval, 2500 pulses per session at 100% of motor threshold (MT).
Device: rTMS
The patients on this group will receive any rTMS intervention. The purpose of this gruop is to compare all clinical, cognitive variables and BDNF levels under conditions of no cocaine/crack consumption, i.e., controlled environments, without rTMS.
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.
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
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: T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase
Psychological problems
The self-administered 90-item Symptoms Checklist-90 (SCL90) will be used.
Time frame: T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase
Addiction severity
The structured interview Addiction Severity Index Lite (ASI-Lite) wil be used to evaluate severity regarding the use of drugs and alcohol.
Time frame: T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase
Previous cocaine-crack comsumption
A retrospective calendar-based self report will be used to measure days of consumption previous to the study enrollment.
Time frame: T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase
Motivation to change
The 32-item self-administered form of University of Rhode Island Change Assessment (URICA) will be used.
Time frame: T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase
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Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente