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Effects of tDCS on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder

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Erasmus University

Status

Completed

Conditions

Cocaine Addiction

Treatments

Device: transcranial Direct Current Stimulation (tDCS)

Study type

Interventional

Funder types

Other

Identifiers

NCT03025321
NL57262.078.16

Details and patient eligibility

About

Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) reduces craving and seems to decrease relapse risk in addiction. However, little is known about the relapse rates in cocaine addiction after tDCS, despite the need for neurobiological treatments to reduce the high relapse rates in this population. The current study explores the effects of repetitive tDCS in a larger sample (N=60) of cocaine addicted patients on number of relapse days after three months. We expect that a decrease in relapse risk after tDCS is associated with cognitive control functioning. Therefore, risky decision making and inhibitory control will be measured before and after the interventions, and at three months follow-up. Ecological momentary assessment (EMA) will be used as a reliable measure for relapse, craving and mood.

Full description

For this study, 60 cocaine addicted patients will receive real or sham bilateral tDCS (left cathodal/right anodal) over the DLPFC after one week in detox. The participants will receive this two times daily for 5 consecutive days. It is expected that this particular tDCS method will reduce relapse probability, as was previously seen in alcohol addicted patients. Furthermore, it is hypothesized that this therapeutic effect is associated with diminished craving and enhanced cognitive control. Craving, temptations and relapse, will be explored by means of Ecological Momentary Assessment (EMA). The mixed results in previous studies of tDCS on craving may be explained by the fact that craving in addiction is a momentary phenomenon which is difficult to reliably measure with more traditional methods like retrospective self-reports, for which EMA provides a solution. Cognitive control will be measured by means of inhibitory control during a Go/NoGo task and reward processing during a gambling task. The tasks will be performed at baseline, one day after the tDCS sessions and at three months follow up.

Enrollment

59 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged between 18 and 65 years
  • Meeting the DSM-V criteria for cocaine dependence
  • The ability to speak, read, and write in Dutch at an eight-grade literacy level
  • No severe withdrawal signs or symptoms at baseline

Exclusion criteria

  • Indications of severe psychopathology (psychosis, severe mood disorder) as assessed by a physician
  • A diagnosis of epilepsy, convulsions or delirium tremens during abstinence of cocaine use
  • Any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants
  • Pregnancy or breast-feeding.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

59 participants in 2 patient groups

transcranial direct current stimulation
Experimental group
Description:
This group will receive bilateral tDCS (left cathodal/right anodal) over the DLPFC. The stimulation will take place two times daily for 13 minutes with a rest interval of 20 minutes for five consecutive days.
Treatment:
Device: transcranial Direct Current Stimulation (tDCS)
Sham tDCS
Sham Comparator group
Description:
The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
Treatment:
Device: transcranial Direct Current Stimulation (tDCS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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