Cocaine AddictionNCT03025321
Effects of tDCS on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder
A study testing transcranial Direct Current Stimulation (tDCS) in people with Cocaine Addiction, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Addiction
- What is being tested?
- transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Feb 2017to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Electrical Neuromodulation on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder: A Multi-Session tDCS Study
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.
Read the 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
- Being tested
- transcranial Direct Current Stimulation (tDCS)
- Keywords
- Cocaine, tDCS, EMA, Inhibitory control, Reward processing, Addiction, dlPFC, craving, cognitive control
- Medical subject headings
- Cocaine-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Secondary outcomes (5)
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.
Measured: 2 weeks
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
Measured: 2 weeks
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
Measured: 2 weeks
Inhibitory control
3 times measured by means of a cocaine related Go/NoGo task
Measured: at baseline and one day after tDCS and at three months follow-up
Reward processing
3 times measured by means of a gambling task
Measured: at baseline and one day after tDCS and at three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start6 Feb 2017
- Primary completion26 Nov 2018
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingmar Franken, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025321
- Sponsor's protocol ID
- NL57262.078.16
- Status last verified
- Mar 2020
- First submitted
- 5 Jan 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33250383
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electrical Neuromodulation on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder: A Multi-Session tDCS Study
- ClinicalTrials.gov ID
- NCT03025321
- Acronym / sponsor ID
- NL57262.078.16
- Conditions
- Cocaine Addiction
- Keywords
- Cocaine, tDCS, EMA, Inhibitory control, Reward processing, Addiction, dlPFC, craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation | Experimental | Device: transcranial Direct Current Stimulation (tDCS)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. |
| Sham tDCS | Sham comparator | Device: transcranial Direct Current Stimulation (tDCS)The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Sham tDCS, transcranial direct current stimulation |
Primary outcome
Number of relapse days at three months follow-up
Time frame: three months
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.
5 secondary outcomes
Number of relapse days at one week after the last tDCS session
Time frame: 2 weeks
Craving
Time frame: 2 weeks
Mood
Time frame: 2 weeks
Inhibitory control
Time frame: at baseline and one day after tDCS and at three months follow-up
Reward processing
Time frame: at baseline and one day after tDCS and at three months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 33250383Verveer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation (tDCS) in people with Cocaine Addiction, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of relapse days at three months follow-up (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03025321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.