NCT03025321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

January 5, 2017

Last Update Submit

March 16, 2020

Conditions

Cocaine Addiction

Keywords

CocainetDCSEMAInhibitory controlReward processingAddictiondlPFCcravingcognitive control

Outcome Measures

Primary Outcomes (1)

  • 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.

    three months

Secondary Outcomes (5)

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

    2 weeks

  • Craving

    2 weeks

  • Mood

    2 weeks

  • Inhibitory control

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

  • Reward processing

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

Study Arms (2)

transcranial direct current stimulation

EXPERIMENTAL

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)

Sham tDCS

SHAM COMPARATOR

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

Device: transcranial Direct Current Stimulation (tDCS)

Interventions

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.

Sham tDCStranscranial direct current stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antes

Rotterdam, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 33250383DERIVED

MeSH Terms

Conditions

Cocaine-Related DisordersBehavior, Addictive

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 19, 2017

Study Start

February 6, 2017

Primary Completion

November 26, 2018

Study Completion

March 8, 2019

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

NL(1)