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

Primary Purpose

Cocaine Addiction

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS)
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Addiction focused on measuring Cocaine, tDCS, EMA, Inhibitory control, Reward processing, Addiction, dlPFC, craving, cognitive control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Antes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

transcranial direct current stimulation

Sham tDCS

Arm 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.

The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.

Outcomes

Primary Outcome Measures

Number of relapse days at three months follow-up
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

Number of relapse days at one week after the last tDCS session
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
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
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
3 times measured by means of a cocaine related Go/NoGo task
Reward processing
3 times measured by means of a gambling task

Full Information

First Posted
January 5, 2017
Last Updated
March 16, 2020
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03025321
Brief Title
Effects of tDCS on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder
Official Title
Effects of Electrical Neuromodulation on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder: A Multi-Session tDCS Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction
Keywords
Cocaine, tDCS, EMA, Inhibitory control, Reward processing, Addiction, dlPFC, craving, cognitive control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcranial direct current stimulation
Arm Type
Experimental
Arm 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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Intervention Description
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 Measure Information:
Title
Number of relapse days at three months follow-up
Description
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.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Number of relapse days at one week after the last tDCS session
Description
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.
Time Frame
2 weeks
Title
Craving
Description
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
Time Frame
2 weeks
Title
Mood
Description
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
Time Frame
2 weeks
Title
Inhibitory control
Description
3 times measured by means of a cocaine related Go/NoGo task
Time Frame
at baseline and one day after tDCS and at three months follow-up
Title
Reward processing
Description
3 times measured by means of a gambling task
Time Frame
at baseline and one day after tDCS and at three months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Antes
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
33250383
Citation
Verveer I, van der Veen FM, Shahbabaie A, Remmerswaal D, Franken IHA. Multi-session electrical neuromodulation effects on craving, relapse and cognitive functions in cocaine use disorder: A randomized, sham-controlled tDCS study. Drug Alcohol Depend. 2020 Dec 1;217:108429. doi: 10.1016/j.drugalcdep.2020.108429. Epub 2020 Nov 23.
Results Reference
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Effects of tDCS on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder

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