Clinical Trial: Effects of Repetitive tDCS on Relapse in Cocaine Addiction: EMA Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Effects of Repetitive tDCS on Relapse in Cocaine Addiction: An Ecological Momentary Assessment (EMA) Study

Brief Summary: Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and relapse risk. However, little is known about the relapse rates in cocaine addiction after tDCS, despite the need for new treatment interventions to reduce the high relapse rates in cocaine addiction. The investigators aim to explore the effects of repetitive tDCS in a larger sample (N=80) of cocaine addicted patients on number of relapse days after three months. In addition, the underlying working mechanism will be explored (e.g. cognitive control functioning). Ecological momentary assessment (EMA) will be used to measure relapse, craving and mood since retrospective self-reports seem to be less reliable in this respect.

Detailed Summary: For this study, 80 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.
Sponsor: Erasmus Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: Erasmus Medical Center

Dates:
Date Received: January 5, 2017
Date Started: January 2017
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017