Cocaine Use Disorder
Conditions
Keywords
rTMS, Craving, Mood and cognitive behavior, Substance-Related Disorders
Brief summary
The study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation (rTMS), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8 weeks following the treatment in addicted patients with cocaine use disorders (CUD) versus placebo.
Detailed description
40 patients are expected and randomized in two groups: 20 patients with active rTMS and 20 with placebo rTMS. Visit 1: 15 days (3 weeks of 5 consecutive daily sessions and 2 days of rest) 15Hz rTMS is performed during the following days in addition to a biweekly urine drug test and VAS evaluation. Visit 2: Changes from baseline to week 8 in cocaine intake. Evaluation of craving and of other assessments like mood and quality of life.
Interventions
OTHERrTMS
rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* male and female patients between 18 and 65 years of age * patients who meet the criteria for CUD reported in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) * positivity to cocaine use, determined via an urine drug test * patients who are able to provide a written informed consent, after being notified about the treatment and the study protocol
Exclusion criteria
* major depression disorder, schizophrenia, bipolar disorder or other psychosis that meet the diagnostic criteria of the DSM-V * illiteracy or cognitive impairment disorders * women who are pregnant or lactating * other medical diseases that contraindicate rTMS treatment such as epilepsy * presence of devices, i.e. pace-makers or cochlear prosthesis * previous rTMS treatments in order to avoid confounding factors * patients who can not provide the written informed consent * DSM-V substance use disorders other than CUD. Only tobacco smoke is allowed to be recruited in the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cocaine intake | 8 weeks following the treatment | Baseline was defined as cocaine consumption before randomization (visit 0). Baseline will be determined using an urine drug test.Changes from baseline to week 8 in cocaine intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Craving first measure | 8 weeks following the treatment | Baseline will be determined using the Visual Analogic Scale (VAS) that is a ordinal scale ranging from 0 to 10. being 0 no craving and 10 maximum craving. Changes from baseline to 8 week |
| Craving second measure | 8 weeks following the treatment | Baseline will be assessed using Cocaine Craving Questionnaire (CCQ), that is a ordinal scale ranging from 0 and 45, being 0 no craving and 45 maximum craving. |
Countries
Italy
Outcome results
None listed