Clinical trial NCT03025321: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Addiction
Keywords: Cocaine
tDCS
EMA
Inhibitory control
Reward processing
Addiction
dlPFC
craving
cognitive control
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of relapse days at three months follow-up
timeFrame: three months
Secondary outcomes:
measure: Number of relapse days at one week after the last tDCS session
timeFrame: 2 weeks
measure: Craving
timeFrame: 2 weeks
measure: Mood
timeFrame: 2 weeks
measure: Inhibitory control
timeFrame: at baseline and one day after tDCS and at three months follow-up
measure: Reward processing
timeFrame: at baseline and one day after tDCS and at three months follow-up
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Antes
Study officials:
References:
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.