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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
Sponsor:
Collaborator:
Studio Gallimberti Bonci & Partners
Information provided by (Responsible Party):
Fondazione Novella Fronda

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants recruited after referral to specialty outpatient clinic Center for Addiction and meeting diagnostic criteria for Cocaine Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM 5), as assessed by an SUDs expert clinical psychiatrist.
Criteria

Inclusion Criteria:

- Current diagnosis of CUD according to DSM-5;

Exclusion Criteria:

  • Pregnancy or breastfeeding;
  • Current DSM-5 diagnosis for Schizophrenia Spectrum and Other Psychotic Disorders, Major Depressive Disorder or Bipolar and Related Disorders;
  • Current DSM-5 diagnosis for Alcohol and Substance use disorders (except Tobacco use disorders);
  • Current DSM-5 diagnosis for Personality disorders;
  • Current DSM-5 diagnosis for Primary Sleep-Wake Disorders;
  • Prior history of un unstable medical illness, substantial neurological illness, any contraindication for rTMS (including implanted metal and devices in the body, and history of epilepsy);

Information from the National Library of Medicine

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


Contacts
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Contact: Graziella Madeo, MD, PhD 0039 3920170804 graziemadeo@gmail.com
Contact: Luis J Gómez Pérez, MSc 0039 3286086304 luigomper@gmail.com

Locations
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Italy
Studio Gallimberti Bonci & Partners Recruiting
Padua, Italy, 35139
Contact: Graziella Madeo, MD, PhD    0039 392 0170804    graziemadeo@gmail.com   
Contact: Stefano Cardullo, PhD    0039 340 2575589    stefano.cardullo@gmail.com   
Sponsors and Collaborators
Fondazione Novella Fronda
Studio Gallimberti Bonci & Partners
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione Novella Fronda
ClinicalTrials.gov Identifier: NCT03733821    
Other Study ID Numbers: SL33P0NCUDTM2TR34T3D
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Novella Fronda:
rTMS
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders