Cocaine DependenceNCT06189690
Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder
A study testing rTMS in people with Cocaine Dependence, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jan 2022to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Psiquiatría Ramón de la Fuente M.
Mexico City, Tlalpan, 14370
Erik D. Morelos-Santana, Ph D. Candidate, 525541605303, emorelos@imp.edu.mx
About this study
Official title: Effects of 5-Hz Repetitive Transcranial Magnetic Stimulation on Serum Brain Derived Neurotrophic Factor and Clinical Variables in Cocaine Use Disorder
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.
Read the detailed description
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.
- Conditions
- Cocaine Dependence
- Being tested
- rTMS
- Keywords
- Craving, BDNF, rTMS, DLPFC
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF
Serum BDNF levels will be measured by an ELISA kit following the manufacturer's instructions.
Measured: 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.
Measured: T0 before the intervention, T1: after rTMS 2 weeks, T2: after 12 weeks maintenance phase
Secondary outcomes (2)
Depression
The 17-item Hamilton Depression Rating Scale (HAM-D) will be used,
Measured: 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.
Measured: T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start6 Jan 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Erik D. Morelos-Santana, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189690
- Sponsor's protocol ID
- TMS-Coc-BDNF
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 5-Hz Repetitive Transcranial Magnetic Stimulation on Serum Brain Derived Neurotrophic Factor and Clinical Variables in Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT06189690
- Acronym / sponsor ID
- TMS-Coc-BDNF
- Conditions
- Cocaine Dependence
- Keywords
- Craving, BDNF, rTMS, DLPFC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rTMS 5 Hz group | Experimental | Device: rTMSTwo-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). |
| Sham group | Sham comparator | Device: rTMSTwo-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). |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSRepetitive 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. | Device | Sham group, rTMS 5 Hz group |
Primary outcome
BDNF
Time frame: T0 before the intervention, T1: after rTMS 2 weeks, T2: after 12 weeks maintenance phase
Serum BDNF levels will be measured by an ELISA kit following the manufacturer's instructions.
Cocaine craving
Time frame: T0 before the intervention, T1: after rTMS 2 weeks, T2: after 12 weeks maintenance phase
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.
2 secondary outcomes
Depression
Time frame: T0 before the intervention, T1: after rTMS 2 weeks, T2: after 12 weeks maintenance phase
Anxiety
Time frame: T0 before the intervention, T1: after rTMS2 weeks, T2: after 12 weeks maintenance phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Cocaine Dependence, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik D. Morelos-Santana, Ph D. Candidate (5255416053503, emorelos@imp.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF (time frame: T0 before the intervention, T1: after rTMS 2 weeks, T2: after 12 weeks maintenance phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.