Substance Use Disorders Clinical Trial
— BRAINSWITCHOfficial title:
Cracking Addiction: Does BRAIN Stimulation-induced Neuroplasticity Reverse Prefrontal Cortex Hypoactivity in Cocaine and neW stImulanTs addiCtion in Humans? (BRAIN SWITCH)
Background: Cocaine use disorders (CUD) is a complex brain disorder, involving several brain
areas and neurocircuits. Effective treatments for CUD are still needed. Repetitive
transcranial magnetic stimulation (rTMS) stimulates non-invasively parts of the brain.
Preliminary data suggest that rTMS may help reducing cocaine craving and consumption.
Researchers want to learn how the brain and the drug-seeking behavior may change with this
treatment.
Objectives: To test if rTMS can reduce cocaine craving and use, and also affect several mood,
behavioral and cognitive alterations associated with prolonged cocaine use.
Eligibility: Healthy, right-handed adults ages 18-65 who do have cocaine use disorder
(moderate to severe).
Design: This is a randomized, double-blind, sham-controlled study. The study includes three
phases: 1) a rTMS continued treatment phase; a rTMS follow-up; and a no rTMS follow-up.
Prior to participating, participants will be screened with:
- Questionnaires
- Medical history
- Physical exam
- Urine tests
- MRI (structural)
After being enrolled, baseline behavioral and imaging data will be collected. In particular,
participants will undergo:
- Questionnaires
- Functional MRI
During the continued rTMS phase, participants with cocaine use disorder will be randomized to
receive real or fake rTMS. Repetitive TMS will be delivered during 10 outpatient treatment
days, over 2 weeks (5 days/week). Following this phase, subjects will have 12 follow-up
visits (once/weekly), during which they will receive rTMS, and behavioral and imaging
assessments will be performed. At the end of the rTMS follow up period, participants will
further receive 3 follow up visits (once a month), during which rTMS will not be performed,
but behavioral data will be collected.
Treatment includes:
- rTMS: A coil is placed on the head. A brief electrical current passes through the coil.
At each visit, participants will receive two rTMS sessions, with a 1hr interval between
sessions. At the beginning of each rTMS session, they view cocaine-related images for
few minutes.
- MRIs at baseline and at follow-up visit #12: Participants lie on a table that slides
into a cylinder that takes pictures of the brain. They respond to images while in the
scanner.
- Repeat of screening tests and questionnaires
- Urine toxicological screen
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 1, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Current diagnosis of cocaine use disorder (from moderate to severe), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5); 2. Abstinence from cocaine for at least 48 hrs. Exclusion Criteria: 1. Current DSM-5 diagnosis of substance and/or alcohol use disorders other than nicotine; 2. Current DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder; 3. 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); 4. 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; 5. Any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures; 6. Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient; 7. For female patients: Pregnancy/breastfeeding. 8. Subjects who have contraindications to MRI. Some of the exclusions are: 1. Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or ferromagnetic fragments in the eye or oral cavity as these make having an MRI unsafe. 2. Unable to lie flat on the back for the expected length of the experiment (50 minutes). 3. Have an abnormality on the brain imaging or neurologic examination not related to the diagnosis. 4. Uncomfortable being in a small space for the expected length of the experiment (50 minutes). 5. Non-removable body piercing or tattoo posing MRI risk 6. Pregnancy |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Neuroscience, Imaging and Clinical Sciences | Chieti | |
Italy | La Promessa ONLUS | Rome |
Lead Sponsor | Collaborator |
---|---|
ITAB - Institute for Advanced Biomedical Technologies |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Brief Version of Cocaine Craving Questionnaire (Brief-CCQ) Total score | Brief Version of Cocaine Craving Questionnaire (Brief-CCQ) is a 10-item scale that evaluates craving for cocaine. Each Brief-CCQ item is rated on a 1 to 7 scale. The Brief-CCQ Total score ranges from 10 (min) to 70 (max). Higher Brief-CCQ scores indicate higher cocaine craving levels. | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months | |
Primary | Change in cocaine consumption as assessed by Timeline Follow Back (TLFB) | Cocaine consumption will be assessed using the TimeLine Follow Back (TLFB). TLFB is an interview-based assessment. Using a calendar, participants are guided through the process of recalling and reporting daily substance consumption. TLFB provides measures of cocaine consumption per week, cocaine consuming days per week, heavy cocaine consuming days per week. | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months | |
Primary | Change in cocaine consumption as assessed by Urine Drug Screen (UDS) | Cocaine consumption will be evaluated by Urine Drug Screen (UDS). Urine Drug Screen is a painless test to evaluate the presence of cocaine and other substances of abuse in urine samples. Quantitative analyses are not performed. Test may be positive or negative for the presence of cocaine and other substances. | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months | |
Secondary | Changes in 90 Symptom Checklist (SCL-90) Global indices | The Symptom Checklist-90 (SCL-90) is a 90-item self-report psychometric instrument. It takes 12-15 minutes to administer. Each item is rated on a scale from 0 (not at all) to 5 (extremely). The global Indices include the General Severity Index (GSI), which is the average rating to all 90 items, the Positive Symptom Total (PST), which is the number of symptoms complained (items scored above zero), and the Positive Symptom Distress Index (PSDI), which is the average rating given to complained symptoms (items scored above zero). | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months | |
Secondary | Changes in Montgomery-Asberg Depression Scale (MADRS) Total Score | The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms. | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months | |
Secondary | Changes in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as "anxious mood", "tension" or "fears". Each item is scored on a 5-point scale, ranging from 0 (not present) to 4 (severe). Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max). | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months | |
Secondary | Changes in the Frontal Assessment Battery (FAB) Total Score | Frontal Assessment Battery (FAB) is a short neuropsychological tool aimed at assessing executive functions. The FAB consists of six subtests, each exploring functions related to the frontal lobes: conceptualization (by means of a similarities task), mental flexibility (by means of a phonological fluency task), motor programming (by means of Luria's motor series), sensitivity to interference (by means of a conflicting instructions task), inhibitory control (by means of a go-no-go task), and environmental autonomy (by means of evaluation of prehension behavior). Each subtest score may range from 0 (min) to 3 (max); total score is from 0 (min) to 18 (max). Higher scores indicate better performance. | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months | |
Secondary | Changes in Eriksen Flanker Test | The Eriksen Flanker Task is a set of response inhibition tests used to assess the ability to suppress responses that are inappropriate in a particular context. The target is flanked by non-target stimuli which correspond either to the same directional response as the target (congruent flankers), to the opposite response (incongruent flankers), or to neither (neutral flankers). A directional response (usually left or right) is assigned to a central target stimulus. Each task begin with a short instruction phase followed by 20 practice trials and 100 experimental trials. The stimuli are displayed for 1500 msec. The measures of performance in each condition is the median reaction time (RT) for correct trials and the proportion of errors. | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months | |
Secondary | Changes in the Iowa Gambling Task (IGT) Performance | The Iowa Gambling Task is a computerized card game commonly used to measure risky decision making tendencies and sensitivity to reward and loss. Performance is calculated on the total net score results from the subtraction of the disadvantageous deck choices from the advantageous deck choices during the entire test ([C'+D']-[A'+B']). | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months | |
Secondary | Changes in Snaith Hamilton Pleasure Scale (SHAPS) Total Score | The Snaith Hamilton Pleasure Scale (SHAPS) is a 14-item self-report scale designed to measure hedonic-tone/anhedonia. Each item is scored on a 4-point scale, ranging from 0 (not at all) to 3 (extremely). Sum the scores from all 14 parameters gives the SHAPS Total Score which may range from 0 (min) to 42 (max). | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months | |
Secondary | Changes in Temporal experience of Pleasure Scale (TEPS) Total Score | The Temporal experience of Pleasure Scale (TEPS) is a 18-item self-report scale designed to evaluate individual trait dispositions in anticipatory and consummatory pleasure experiences. Each item is scored on a 6-point scale, ranging from 1 (extremely false) to 6 (extremely true). Sum the scores from all 20 parameters gives the TEPS Total Score which may range from 20 (min) to 108 (max). | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months | |
Secondary | Changes in Profile of Mood States (POMS), Total Mood Disturbance Score | The profile of mood state (POMS) is a questionnaire designed to measure present mood state by a list of adjectives on a 5-point Likert scale (0 = not at all; 4 = Extremely) and measures six dimensions of affect, including tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. The measure has been shown to produce reliable and valid profiles of mood state. A Total Mood Disturbance Score may be calculated by adding the scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the score for Vigour. | Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months |
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