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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03025321
Enrollment
59
Registered
2017-01-19
Start date
2017-02-06
Completion date
2019-03-08
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Addiction

Keywords

Cocaine, tDCS, EMA, Inhibitory control, Reward processing, Addiction, dlPFC, craving, cognitive control

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.

Interventions

DEVICEtranscranial 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.

Sponsors

Erasmus Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of relapse days at three months follow-upthree monthsIn 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

MeasureTime frameDescription
Number of relapse days at one week after the last tDCS session2 weeksIn 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.
Craving2 weeksParticipants 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
Mood2 weeksParticipants 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 controlat baseline and one day after tDCS and at three months follow-up3 times measured by means of a cocaine related Go/NoGo task
Reward processingat baseline and one day after tDCS and at three months follow-up3 times measured by means of a gambling task

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026