Clinical Trial: Treatment With Transcranial Magnetic Stimulation for Cocaine Addiction: Clinical Response and Functional Connectivity.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effects of Transcranial Magnetic Stimulation on Functional Connectivity and Response to Treatment of Cocaine Dependent Patients

Brief Summary: The purpose of this study is to investigate the short and long term clinical and cognitive effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz frequencies on the left dorsolateral prefrontal cortex in cocaine dependent patients and to examine possible changes in brain structure and functional connectivity associated with this intervention.

Detailed Summary:

Repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce craving in cocaine addicts in the short term. However, there are no studies on the long term clinical and cognitive effects of sustained rTMS therapy. Moreover, clinical improvement or decline could be related to long term changes in brain structure and function. The purpose of this study is to investigate the short and long term clinical and cognitive effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz frequencies on the left dorsolateral prefrontal cortex in cocaine dependent patients and to examine possible changes in brain structure and functional connectivity associated with this intervention. For this purpose the investigators will recruit cocaine dependent patients and stimulate them using rTMS with a acute intervention (twice a day for 2 weeks) and a maintenance intervention (twice a week for 12 months). The investigators will follow the patients to determine clinical outcome. The investigators will also measure clinical, cognitive and brain structural and functional connectivity to asses changes related to the intervention in the short and long term (measurements at: baseline, 2 weeks, 3 months, 6 months and 12 months).

Procedure:

The projects consists of: Screening Visit, Part 1 and Part 2.

First, there will be a screening visit, where a clinical interview will be conducted and tests will be applied to select study participants who meet the inclusion and exclusion criteria.

Baseline clinical, cognitive and neuroimaging data will be acquired. The cognitive and neuroimaging data will be exploratory, to be associated with the outcome measures. Part 1 of the study entails the determination of the rTMS target fre
Sponsor: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Current Primary Outcome:

  • Change in Cocaine Craving (CCQ) [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    The craving will be measured using a craving questionnaire for cocaine validated in Mexican population (Cocaine Craving Questionnaire or CCQ) before and after each treatment of rTMS.
  • Change in Cocaine Craving (VAS) [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    The craving will be measured using a 100 mm visual analogue scales (VAS).
  • Lapse rate [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    Lapse is defined as at least one consumption event not in the same pattern as the baseline consumption. The report of self-consumption of cocaine and urine drug tests, with special attention to the presence of traces of cocaine.
  • Relapse rate [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    Relapse is defined as consumption events in the same pattern as the baseline consumption. The report of self-consumption of cocaine and urine drug tests, with special attention to the presence of traces of cocaine.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in Psychopathological Symptoms [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    Measured by the 90 Symptoms Questionnaire (SCL-90).
  • Changes in Depression [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    Measured by Hamilton Depression Rating Scale (HDRS) (21 items).
  • Changes in Anxiety [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    Measured by Hamilton Anxiety Rating Scale (HARS).
  • Changes in Drug Consumption and Related Problems [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    Measured by the Addiction Severity Index (ASI-lite).
  • Changes in Sleep Quality. [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    Measured by the Pittsburgh Sleep Quality Index (PSQI).
  • Changes in Impulsivity [ Time Frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months. ]
    Measured by the Barrat Impulsivity Scale-11 (BIS-11).


Original Secondary Outcome: Same as current

Information By: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Dates:
Date Received: December 2, 2016
Date Started: December 2016
Date Completion: December 2019
Last Updated: December 5, 2016
Last Verified: December 2016