Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder

NCT06189690 | Recruiting

• 1 other identifier: TMS-Coc-BDNF
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

Craving; BDNF; rTMS; DLPFC

Outcome Measures

Primary Outcomes (2)

• BDNF

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

  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.

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

Secondary Outcomes (2)

• Depression

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

• Anxiety

  T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase

Other Outcomes (4)

• Psychological problems

  T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase

• Addiction severity

  T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase

• Previous cocaine-crack comsumption

  T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase

Study Arms (3)

rTMS 5 Hz group

EXPERIMENTAL

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

Sham group

SHAM COMPARATOR

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

no rTMS control group

NO INTERVENTION

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.

Interventions

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.

Sham group; rTMS 5 Hz group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• If the patient does not meet the safety criteria for rTMS.
• Current use of any medication that might provoque seizures or any anticonvulsant drugs.
• Personal history of schizophrenia, mania/hypomania or OCD.
• Personal history of myocardial infarction, angina, congestive heart failure, cerebrovascular events, transient ischemic attack or any other heart condition currently undergoing medical treatment.
• Personal history of seizures or detection of paroxysmal EEG activity.

Sponsors & Collaborators

• Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Instituto Nacional de Psiquiatría Ramón de la Fuente M.

Mexico City, Tlalpan, 14370, Mexico

RECRUITING

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Erik D. Morelos-Santana, Ph D. Candidate

CONTACT

5255416053503; emorelos@imp.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: January 6, 2022
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

ME (1)