Subjective Sleep Quality in CUD TMS-Treated
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|ClinicalTrials.gov Identifier: NCT03733821|
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : February 13, 2020
Sleep disruptions are prevalent complaints in cocaine use disorder (CUD) subjects, either during consumption or withdrawal. Repetitive transcranial magnetic stimulation (rTMS) seem to be a promissing strategy in the treatment of chronic cocaine users.
The aim of this study will be to assess the variation on self-perceived sleep quality and drug use variables in individuals with CUD undergoing a rTMS protocol over the left dorsolateral prefrontal cortex (DLPFC).
|Condition or disease||Intervention/treatment|
|Cocaine Use Disorder Sleep Disturbance||Device: Repetitive Transcranial Magnetic Stimulation|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Sleep Modifications in Patients With Cocaine Use Disorders Treated With Transcranial Magnetic Stimulation (TMS)|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
CUD patients on HF-rTMS treatment
Patients fulfilling the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM 5) criteria for Cocaine Use Disorder undergoing a High Frequency rTMS protocol stimulating over the left dorsolateral prefrontal cortex (DLPFC).
Device: Repetitive Transcranial Magnetic Stimulation
Non-invasive brain stimulation tool
- High frequency rTMS effects on subjective sleep quality in CUD patients [ Time Frame: Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions) ]The subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). This scale is composed by 19 items clustered into 7 components, including sleep duration, sleep disturbance, sleep latency, daytime dysfunction, sleep efficiency, overall sleep quality, and sleep medication use. Each of them generates a score ranging from 0 to 3, with the highest value indicating the greatest dysfunction. The sleep component scores are summed to produce a global score ranging from 0 to 21 with the higher score indicating worse sleep quality. A global score higher than 5 is considered an indicator of relevant sleep disturbances.
- High frequency rTMS effects on self-reported craving in CUD patients [ Time Frame: Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions) ]Self-reported craving will be assessed by Cocaine Craving Questionnaire (CCQ) which is a 5-item self-report questionnaire measuring five aspects of craving: current intensity, intensity during the previous 24 h, frequency, responsiveness to drug-related conditioned stimuli, and imagined likelihood of use if in a setting with access to drugs. Each craving aspects yields a score ranging from 0 to 9 with the highest values indicating high craving. The overall score is obtained by summing every item score and dividing it by 5. A higher mean craving score is associated with less likeliness to initiate abstinence.
- High frequency rTMS effects on Depression Symptoms in CUD patients [ Time Frame: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions) ]Depression symptoms will be assessed by Beck Depression Inventory - II (BDI - II) which is a 21-question multiple-choice self-report inventory with four options under each item, ranging from not present (0) to severe (3), measuring depressive symptoms. This inventory scoring is obtained by summing the highest ratings for each of the 21 items, with a sum scores range from 0 to 63. The severity levels suggested in the manual are the following: Scores between 0 and 13 indicate minimal, between 14 and 19 mild, between 20 and 28 moderate, and between 29 and 63 severe depression.
- High frequency rTMS effects on Anxiety Symptoms in CUD patients [ Time Frame: Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions) ]Anxiety symptoms will be assessed by Self-rating Anxiety Scale (SAS) which is is a 20-item measure developed to assess the frequency of anxiety symptoms based on diagnostic conceptualizations. It consists primarily of somatic symptoms. Each symptom is rated on a 4-point Likert scale on frecuency basis from 1 ('"none or a little of the time'") to 4 ('"most or all of the time''). Items 5, 9, 13, 17, and 19 are reversed scored and total scores on the SAS range from 0 to 80, with higher scores indicating more frequents anxiety symptoms.
- High frequency rTMS effects on subjective symptoms of mental disorder in CUD patients [ Time Frame: Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions) ]Subjective symptoms of mental disorder will be assessed by Symptoms checklist 90 - Revised (SCL-90-R) which is is a 90-item self-report inventory which assesses psychological distress in terms of nine primary symptom dimensions and three summary scores termed global scores. Each item describes a physical or psychological symptomthat is rated on a five-point scale ranging from 1 (not at all) to 5 (extremely). The Global Severity Index (GSI) is the single best indicator of the current level or depth of an individual's disorder. It combines information concerning the number of symptoms reported with the intensity of perceived distress.
- High frequency rTMS effects on cocaine intake [ Time Frame: Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions) ]Cocaine intake will be determined determined either via a urine drug test or referral reported relapse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733821
|Contact: Graziella Madeo, MD, PhD||0039 email@example.com|
|Contact: Luis J Gómez Pérez, MSc||0039 firstname.lastname@example.org|
|Principal Investigator:||Michela Sarlo, Assoc. Prof.||Department of General Psychology, University of Padova|
|Study Chair:||Nicola Cellini, PhD||Department of General Psychology, University of Padova|
|Study Chair:||Stefano Cardullo, PhD||Fondazione Novella Fronda|