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

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ClinicalTrials.gov Identifier: NCT03025321
Recruitment Status : Not yet recruiting
First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ingmar Franken, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Cocaine Addiction Device: transcranial Direct Current Stimulation (tDCS) Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Repetitive tDCS on Relapse in Cocaine Addiction: An Ecological Momentary Assessment (EMA) Study
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: transcranial direct current stimulation
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.
Device: transcranial Direct Current Stimulation (tDCS)
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.

Sham Comparator: Sham tDCS
The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
Device: transcranial Direct Current Stimulation (tDCS)
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025321


Contacts
Contact: Ilse Verveer, MSc 0104089588 verveer@fsw.eur.nl
Contact: Ingmar Franken, Prof. Dr. 010 408 9563 franken@fsw.eur.nl

Sponsors and Collaborators
Erasmus Medical Center

Responsible Party: Ingmar Franken, Prof. Dr., Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03025321     History of Changes
Other Study ID Numbers: NL57262.078.16
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

Keywords provided by Ingmar Franken, Erasmus Medical Center:
Cocaine
tDCS
EMA
Inhibitory control
Reward processing
Addiction
dlPFC
craving
cognitive control

Additional relevant MeSH terms:
Cocaine-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents