Cocaine UseBDNFcocaNCT05824221
Effect of rTMS on Neurotrophines Levels in CUD
A study testing rTMS in people with Cocaine Use and Cocaine Dependence, run by ITAB - Institute for Advanced Biomedical Technologies at 1 site in Italy.
Trial summary
Brief Summary: Background: Cocaine use disorders (CUD) is a multifactoral disease, involving several brain areas. One of the most investigated is the Dorsolateral Prefrontal Cortex (DLPFC) involved in impulsiveness control. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use, Cocaine Dependence, Cocaine Abuse
- 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
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current diagnosis of cocaine use disorder (from moderate to severe), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
- Abstinence from cocaine for at least 48 hrs.
- 1. 18-65 years
Who cannot join
- Current DSM-5 diagnosis of substance and/or alcohol use disorders other than nicotine;
- Current DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
- Use in the past 4 weeks of any medication with known pro-convulsant action; or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers);
- Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes;
- Current DSM-5 diagnosis of substance use disorders other than nicotine;
- Current DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
Trial locations and contacts
1 site in 1 country.
Italy1 site
ITAB
Chieti, 66100
Mauro Pettorruso, 3391979487, mauro.pettorruso@unich.it
About this study
Official title: Effect of rTMS on BDNF and proBDNF Levels: a Sham-controlled Study in Subjects With Cocaine Use Disorder
Brief Summary:
Background: Cocaine use disorders (CUD) is a multifactoral disease, involving several brain areas. One of the most investigated is the Dorsolateral Prefrontal Cortex (DLPFC) involved in impulsiveness control. Effective treatments for CUD are still needed and repetitive Transcranial Magnetic Stimulation (rTMS) is widely studied for its potential in reducing cocaine craving and consumption.
Read more
Objectives: The main outcome is to test if rTMS can be related to neuroplasticity and neurotrophism through changes in Brain-Derived Neurotrophic Factor (BDNF) and its precursor (pro-BDNF) levels.
Eligibility: Healthy, right-handed adults ages 18-65 who do have cocaine use disorder (moderate to severe).
Design: This is a randomized, sham-controlled study. The study includes a rTMS continued treatment phase compared to healthy control (HC) evaluation.
Prior to participating, participants will be screened with:
- Medical history
- Anamnestic sheet
- Physical exam
- Urine tests After being enrolled, participants and HC will undergo venous blood sample (BDNF and proBDNF levels).
During the continued rTMS phase, participants with cocaine use disorder will be randomized to receive real or sham rTMS; a former arm is also provided and is made up of HC. RTMS will be delivered in 10 days, over 2 weeks (5 days/week). After the last rTMS session a blood sample for neurotrophines levels will be collected.
Treatment includes:
- rTMS: A coil is placed on the head. At each session, participants will receive two rTMS sessions, with a 50 mins interval. At the beginning of each rTMS session, they view cocaine-related images for few minutes (cue-induced stimuli).
- BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first two weeks), this sample will be also collected from HC. The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis.
- Urine toxicological screen
Read the detailed description
RTMS has been shown to reduce craving in CUD. The purpose of this study is to assess the effects of rTMS at 15 Hz frequency on neurotrophines serum levels . For this purpose, the investigators will recruit cocaine user. After screening and informed consent, participants will undergo active or sham rTMS for two consecutive weeks (twice a day) during the continued treatment phase; a third arm of HC will receive no treatment. A venous blood sample will be collected before the first stimulation and after the last stimulation of the first two weeks treatment.
Procedure: The project consists of: Screening Visit (baseline) and the continued treatment phase, In the screening visit, a clinical interview to assess the eligibility of participant (following the inclusion and exclusion criteria) will be performed. All participants will be randomly assigned to one of the two treatment arms with rTMS (15Hz, 15Hz-Sham). Participants will receive 2 sessions of rTMS (active or sham), twice per day for 10 consecutive days, for a total of 20 rTMS sessions. A venous blood sample will be collected before the first stimulation and after the last stimulation of the continued treatment phase to asses the BDNF and pro-BDNF level.
- Conditions
- Cocaine Use, Cocaine Dependence, Cocaine Abuse, Neurotropism
- Being tested
- rTMS
- Keywords
- rTMS, BDNF, proBDNF, Cocaine Use Disorder
- 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
Non invasive brain stimulation in Cocaine Use Disorder
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS (15 Hz) | Experimental | Active stimulation of LDLPFC (15 Hz; 100% of RMT; 40 trains with 60 stimuli per train; inter-train interval of 15 second, total duration 13 minutes). Each session will be repeated twice/daily for 10 consecutive days for 2 weeks, during the continued treatment phase. Device: MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark). Receives: Device: rTMS |
| Sham rTMS | Sham comparator | A pre-programmed software set sham stimulation by a staff member that will not be involved in data collection and analysis. The sham condition will match the number of pulses delivered during the 15Hz session and will use the same coil placement but the intensity of stimulation will be set a 3% of the RMT so to ensure that the participant will feel similar scalp sensations experienced by participants receiving active rTMS, but brain tissue will not be stimulated. Device: MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark). Receives: Device: rTMS |
| Healthy Control | No intervention | Subject without diagnosis of Cocaine Use Disorder or other major psychiatric disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BDNF level (biological marker)
BDNF levels will be evaluated by collecting a venous blood sample. BDNF is a member of the nerve growth factor (NGF) family of neurotrophic growth factors. The increase in serum levels of BDNF seems to reflect the neuroplasticity of the CUD brain. BDNF measurements will be calculated in pg/ml
Measured: Baseline, two weeks
Change in proBDNF level (biological marker)
Pro-BDNF is the precursor of BDNF and it acts as a repository of mature BDNF and acts itself by inducing neuronal thinning. Pro-BDNF levels will be evaluated by collecting a venous blood sample. Pro-BDNF measurements will be calculated in ng/ml.
Measured: Baseline, two weeks
Change in pro-BDNF/BDNF ratio (biological marker)
Pro-BDNF/BDNF ratio, seems to be a more specific measurement of the early changes in the metabolism of BDNF. Its level seems to correlate to more or less a neurotrophic and neuroprotective action of BDNF. As a ratio it has not a unit measure.
Measured: Baseline, two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start30 Apr 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine UseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, sham-controlled with a 1:1 allocation into 2 parallel arms. A third arm constituted by healthy patients.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ITAB - Institute for Advanced Biomedical Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pettorruso, ITAB - Institute for Advanced Biomedical Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824221
- Sponsor's protocol ID
- brainbdnf
- Acronym
- BDNFcoca
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of rTMS on BDNF and proBDNF Levels: a Sham-controlled Study in Subjects With Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT05824221
- Acronym / sponsor ID
- BDNFcoca / brainbdnf
- Conditions
- Cocaine Use, Cocaine Dependence, Cocaine Abuse, Neurotropism
- Keywords
- rTMS, BDNF, proBDNF, Cocaine Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ITAB - Institute for Advanced Biomedical TechnologiesUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 21 Apr 2023 (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.
Brief Summary:
Background: Cocaine use disorders (CUD) is a multifactoral disease, involving several brain areas. One of the most investigated is the Dorsolateral Prefrontal Cortex (DLPFC) involved in impulsiveness control. Effective treatments for CUD are still needed and repetitive Transcranial Magnetic Stimulation (rTMS) is widely studied for its potential in reducing cocaine craving and consumption.
Objectives: The main outcome is to test if rTMS can be related to neuroplasticity and neurotrophism through changes in Brain-Derived Neurotrophic Factor (BDNF) and its precursor (pro-BDNF) levels.
Eligibility: Healthy, right-handed adults ages 18-65 who do have cocaine use disorder (moderate to severe).
Design: This is a randomized, sham-controlled study. The study includes a rTMS continued treatment phase compared to healthy control (HC) evaluation.
Prior to participating, participants will be screened with:
- Medical history
- Anamnestic sheet
- Physical exam
- Urine tests After being enrolled, participants and HC will undergo venous blood sample (BDNF and proBDNF levels).
During the continued rTMS phase, participants with cocaine use disorder will be randomized to receive real or sham rTMS; a former arm is also provided and is made up of HC. RTMS will be delivered in 10 days, over 2 weeks (5 days/week). After the last rTMS session a blood sample for neurotrophines levels will be collected.
Treatment includes:
- rTMS: A coil is placed on the head. At each session, participants will receive two rTMS sessions, with a 50 mins interval. At the beginning of each rTMS session, they view cocaine-related images for few minutes (cue-induced stimuli).
- BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first two weeks), this sample will be also collected from HC. The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis.
- Urine toxicological screen
Detailed description
RTMS has been shown to reduce craving in CUD. The purpose of this study is to assess the effects of rTMS at 15 Hz frequency on neurotrophines serum levels . For this purpose, the investigators will recruit cocaine user. After screening and informed consent, participants will undergo active or sham rTMS for two consecutive weeks (twice a day) during the continued treatment phase; a third arm of HC will receive no treatment. A venous blood sample will be collected before the first stimulation and after the last stimulation of the first two weeks treatment.
Procedure: The project consists of: Screening Visit (baseline) and the continued treatment phase, In the screening visit, a clinical interview to assess the eligibility of participant (following the inclusion and exclusion criteria) will be performed. All participants will be randomly assigned to one of the two treatment arms with rTMS (15Hz, 15Hz-Sham). Participants will receive 2 sessions of rTMS (active or sham), twice per day for 10 consecutive days, for a total of 20 rTMS sessions. A venous blood sample will be collected before the first stimulation and after the last stimulation of the continued treatment phase to asses the BDNF and pro-BDNF level.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, sham-controlled with a 1:1 allocation into 2 parallel arms. A third arm constituted by healthy patients.
| Arm | Type | Receives |
|---|---|---|
| Active rTMS (15 Hz) | Experimental | Device: rTMSActive stimulation of LDLPFC (15 Hz; 100% of RMT; 40 trains with 60 stimuli per train; inter-train interval of 15 second, total duration 13 minutes). Each session will be repeated twice/daily for 10 consecutive days for 2 weeks, during the continued treatment phase. Device: MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark). |
| Sham rTMS | Sham comparator | Device: rTMSA pre-programmed software set sham stimulation by a staff member that will not be involved in data collection and analysis. The sham condition will match the number of pulses delivered during the 15Hz session and will use the same coil placement but the intensity of stimulation will be set a 3% of the RMT so to ensure that the participant will feel similar scalp sensations experienced by participants receiving active rTMS, but brain tissue will not be stimulated. Device: MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark). |
| Healthy Control | No intervention | –Subject without diagnosis of Cocaine Use Disorder or other major psychiatric disorder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current diagnosis of cocaine use disorder (from moderate to severe), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
- Abstinence from cocaine for at least 48 hrs.
- 1. 18-65 years
Key exclusion criteria (6 listed)
- Current DSM-5 diagnosis of substance and/or alcohol use disorders other than nicotine;
- Current DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
- Use in the past 4 weeks of any medication with known pro-convulsant action; or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers);
- Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes;
- Current DSM-5 diagnosis of substance use disorders other than nicotine;
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 |
|---|---|---|
| rTMSNon invasive brain stimulation in Cocaine Use Disorder | Device | Active rTMS (15 Hz), Sham rTMS |
Primary outcome
Change in BDNF level (biological marker)
Time frame: Baseline, two weeks
BDNF levels will be evaluated by collecting a venous blood sample. BDNF is a member of the nerve growth factor (NGF) family of neurotrophic growth factors. The increase in serum levels of BDNF seems to reflect the neuroplasticity of the CUD brain. BDNF measurements will be calculated in pg/ml
Change in proBDNF level (biological marker)
Time frame: Baseline, two weeks
Pro-BDNF is the precursor of BDNF and it acts as a repository of mature BDNF and acts itself by inducing neuronal thinning. Pro-BDNF levels will be evaluated by collecting a venous blood sample. Pro-BDNF measurements will be calculated in ng/ml.
Change in pro-BDNF/BDNF ratio (biological marker)
Time frame: Baseline, two weeks
Pro-BDNF/BDNF ratio, seems to be a more specific measurement of the early changes in the metabolism of BDNF. Its level seems to correlate to more or less a neurotrophic and neuroprotective action of BDNF. As a ratio it has not a unit measure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Use and Cocaine Dependence, run by ITAB - Institute for Advanced Biomedical Technologies at 1 site in Italy.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauro Pettorruso, MD, PhD (+393391979487, mauro.pettorruso@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BDNF level (biological marker) (time frame: Baseline, two weeks). The study lists 3 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 21 Apr 2023.