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

NCT ID: NCT03025321

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2019-03-08

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.

Conditions

Cocaine Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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 tDCS

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

Group Type: SHAM_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ingmar Franken

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Antes

Rotterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 33250383 (View on PubMed)

Other Identifiers

NL57262.078.16

Identifier Type: -

Identifier Source: org_study_id