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Completed

NCT Number: NCT03025321

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antes

Rotterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

tDCS is an electrical brain stimulation method Participants will receive real-tDCS or sham twice daily for 13 min with an interval of 20 min for five consecutive days.

Primary outcomes

  1. Number of relapse days at three months follow-up

    Time frame: three months

    In an app on the smartphone participants can indicate when they relapsed at any time during 3 months starting from tDCS session 1. Participants will receive a reminder at the end of every week to fill this out.

Secondary outcomes

  1. Number of relapse days at one week after the last tDCS session

    Time frame: 2 weeks

    In an app on the smartphone participants can indicate when they relapsed at any time during 2 weeks starting from tDCS session 1. Participants will receive a reminder at the end of every week to fill this out.

  2. Craving

    Time frame: 2 weeks

    Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 2 weeks starting from tDCS session 1

  3. Mood

    Time frame: 2 weeks

    Participants receive 4 prompts a day in the app on the smartphone to fill out questions about mood during 2 weeks starting from tDCS session 1

  4. Inhibitory control

    Time frame: at baseline and one day after tDCS and at three months follow-up

    3 times measured by means of a cocaine related Go/NoGo task

  5. Reward processing

    Time frame: at baseline and one day after tDCS and at three months follow-up

    3 times measured by means of a gambling task

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Effects of Electrical Neuromodulation on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder: A Multi-Session tDCS Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 19, 2017
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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