Phase 2
Completed N=33
Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in Alcoholism
alcohol dependence · executive dysfunction · Abnormal Craving for Drugs
Source: ClinicalTrials.gov NCT01330394 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Use of Alcohol — 15; 8 participants
Summary
Alcohol dependency is the most frequent addiction leading to a massive burden of both, patients health, and economy. Present therapeutic concepts suffer from limited efficacy, and thus new innovative therapies are needed. Neuroscientific studies have shown that prefrontal function in alcohol-dependent patients is impaired, leading to cognitive disturbances, and continuation of dependent behaviour. The results of pilot studies demonstrate that activation of prefrontal cortices via non-invasive brain stimulation improves cognitive performance in healthy subjects, and diminishes dependency-related behaviour in patients. The investigators aim to develop a stimulation protocol suited to induce a clinically relevant improvement of prefrontal functions in patients suffering from alcohol dependency. Therefore, the investigators will develop stimulation protocols which are able to modulate prefrontal activation for a much longer time course than those currently available, and will explore if the induced physiological alterations translate to respective cognitive improvements and reduction of addictive behaviour.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Use of Alcohol |
15; 8 | — |
| SECONDARY Event-related Potentials |
— | — |
| SECONDARY Cognitive Tasks |
— | — |
| SECONDARY Quality of Life |
— | — |
| SECONDARY Effort to Control the Urge for Use Alcohol |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with diagnosis confirmed by Diagnostic and Statistical Manual of Mental Disorders in its Fourth Edition (DSM-IV);
- Alcoholics classified as type IV according to Lesch's Typology.
- 18-65 years old from both genders;
- clinically stable and not requiring hospitalization;
- with significant history of consumption of at least 35 weekly doses of alcohol on average last year;
- and an active intake of at least 35 weekly doses of alcohol in the last 90 days before starting the study;
- being in a minimum of seven days of abstinence until beginning of the study protocol;
- able to read, write and speak Portuguese.
Exclusion Criteria
- Diagnosis of other drug dependence, except nicotine and caffeine use;
- Diagnosis of other mental disorder
Data sourced from ClinicalTrials.gov (NCT01330394). 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. Informational only — not medical advice.