Phase 2
N=20
Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction
Cocaine Addiction · Cocaine-related Disorder · Executive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01337297 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Abstinence — 71.4; 16.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- transcranial Direct Current Stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Federal University of Espirito Santo
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abstinence |
71.4; 16.6 | — |
| SECONDARY Intensity of the Urge to the Use of Crack-cocaine |
— | — |
| SECONDARY Event Related Potentials |
— | — |
| SECONDARY Cognitive Tests |
— | — |
| SECONDARY State of Depression |
— | — |
Summary
The use of crack-cocaine is growing at alarming rate in our country and it is absolutely worrisome the fast establishment of addiction to it. Its immediate effects, that are intense and extremely fleeting, increase dramatically the probability of this drug to be consumed again, settling quickly down the loss of control and the compulsive use, turning the effects of this drug highly addictive. Parallel to this process, brain damages are quickly established, progressing to severe impairments of frontal functions, leading to the lack of cognitive control that feeds back and aggravates the dependence, and hampers any therapeutic approach. The existing treatments have not proved to be satisfactory yet. Thus, considering that a new modality of treatment, based on the neuromodulation induced by noninvasive brain stimulation, has been useful in treating various neuropsychiatric conditions, this study will examine the potential beneficial effects of repeated transcranial Direct Current Stimulation over the left dorsolateral prefrontal cortex in the treatment of crack-cocaine addiction.
Eligibility Criteria
Inclusion Criteria
- fulfill the criteria for the crack-dependence syndrome, based on criteria of the International Classification of Diseases on its 10th version;
- all users and addicts who make use of crack-cocaine alone or in combination with other drugs (alcohol, nicotine, caffeine, cannabis, etc.), or who have psychiatric comorbidities (anxiety, depression, etc.)
- must be clinically stable and not requiring hospitalization;
- should be clinically suitable for the treatment proposed in this study;
- need to be able to read, write and speak Portuguese
Exclusion Criteria
- should not present current or past illnesses that may be aggravated during treatment;
- may not show abnormalities in laboratory tests which suggest a deterioration of its physical condition for participation in the study;
- individuals who have some metal in the brain or skull (chips, fragments, pins, etc. - except titanium);
- history of epilepsy, severe brain trauma, cochlear implant, cardiac pacemaker or intracardiac metal apparatus);
- pregnants.
Data sourced from ClinicalTrials.gov (NCT01337297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.