Phase 2
N=35
Bilateral Prefrontal Modulation in Crack-cocaine Addiction
Drug Addiction · Executive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT02091167 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Craving — 6.53; 7.0; 4.74; 4.43 scores on a scale — p=0.05
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
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Craving |
6.53; 7.0; 4.74; 4.43; 3.63; 4.0 | 0.05 |
| PRIMARY Relapses |
10; 7; 7; 5; 8; 4 | 0.05 |
Summary
In this study, eligible crack-cocaine addicted inpatients recruited from specialized clinics for substance abuse disorder treatment, filling inclusion criteria and not showing any exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 3x7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine was examined before (baseline), during and after the end of the tDCS treatment.
Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC would favorably change clinical, cognitive and brain function in crack-cocaine addiction and these would be long-lasting effects.
Eligibility Criteria
Inclusion Criteria
- patients between the age of 18 and 60 years;
- met criteria for crack-cocaine dependence according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), as determined by clinical evaluation;
- in stable clinical condition with no need for inpatient care;
- able to read, write, and speak Portuguese; and
- no severe withdrawal signs or symptoms at baseline.
Exclusion Criteria
- a condition of intoxication or withdrawal due to a substance other than crack-cocaine;
- unstable mental or medical disorder or substance abuse or addiction other than crack-cocaine dependence, except nicotine and/or caffeine;
- a diagnosis of epilepsy, convulsions;
- a previous history of drug hypersensitivity or adverse reactions to diazepam or other benzodiazepines and haloperidol;
- any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants;
- suspected pregnancy for female participants;
Data sourced from ClinicalTrials.gov (NCT02091167). 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.