UnknownNot Applicable

Effect of rTMS on Neurotrophines Levels in CUD

Italy60 participantsStarted 2023-04-30

Plain-language 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. 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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

Change in BDNF level (biological marker)

Timeframe: Baseline, two weeks

Change in proBDNF level (biological marker)

Timeframe: Baseline, two weeks

Change in pro-BDNF/BDNF ratio (biological marker)

Timeframe: Baseline, two weeks

Trial details

NCT IDNCT05824221

SponsorITAB - Institute for Advanced Biomedical Technologies

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

Contact for this trial

Mauro Pettorruso, MD, PhD

+393391979487 mauro.pettorruso@unich.it

View on ClinicalTrials.gov More Cocaine Use trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;