TDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study (NCT04994821) | Clinical Trial Compass
CompletedPhase 2
TDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study
United States60 participantsStarted 2020-09-28
Plain-language summary
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In a prior Phase-I study, the research team demonstrated feasibility of self-administration of a home-tDCS prototype in 14 patients that applied 15 sessions for each patient at an outpatient center.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* DSM-5 diagnosis of cocaine use disorder
* Ability to understand the risks/benefits of the study, provide informed consent and perform tasks as per protocol
* English speaking
* For females of childbearing capacity, current use of a medically acceptable form of birth control
Exclusion Criteria:
* Current or past history of a major neurological disorder (e.g. mental retardation, Parkinson's disease, Lewy body disease, Huntington's disease, MS, ALS, stroke, delirium tremens) or seizures, including those symptoms associated with periods of cocaine withdrawal or abstinence
* History of Axis I disorder, other than substance use disorder, that is associated with psychotic symptoms (e.g. schizophrenia) or neurodevelopmental disorder (e.g., autism)
* Use of medications (current or in the past 6 months) with known CNS effects or which may alter cerebral function, except psychotropics for depression/anxiety/PTSD (e.g. SSRIs)
* Clinically significant unstable medical illness or infection (e.g. HIV, hepatitis, etc.)
* Presence of contraindicated metallic implants or devices which may be impacted by electrical stimulation (e.g. cardiac pacemaker/defibrillator, medication pump, cochlear implant, implanted brain stimulator)
* Head trauma with loss of consciousness for more than 30 minutes
* Pregnancy or breast feeding
What they're measuring
1
Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)