120 Participants Needed

tDCS for Cocaine Use Disorder

KR
MB
Overseen ByMaggie Boros Clinical Research Coordinator
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transcranial direct current stimulation (tDCS) can reduce cravings in individuals addicted to cocaine. tDCS is a non-invasive brain stimulation method, and this trial pairs it with Cognitive Reappraisal, a technique that helps individuals rethink their cravings. Participants will undergo brain scans before and after treatment to observe changes in brain activity. The study seeks individuals diagnosed with cocaine use disorder who experience strong cravings impacting their daily life. As an unphased study, it offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for cocaine addiction.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for treating cocaine use disorder?

Research shows that transcranial direct current stimulation (tDCS) is a promising and low-risk treatment. Studies indicate that tDCS can reduce cravings for drugs like cocaine without causing serious side effects. One review confirmed that tDCS does not pose serious risks, such as brain injury.

Cognitive Reappraisal Training is also considered a safe method for managing cocaine addiction. This technique involves changing thoughts about drug-related triggers, which can help reduce cravings. Although specific safety data for this trial phase isn't detailed, cognitive reappraisal is generally viewed as safe.

Both treatments in this trial have been well-tolerated in past studies, suggesting they are potentially safe options for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the tDCS treatments for cocaine use disorder because they offer a novel approach compared to standard options like behavioral therapy and medication. Transcranial Direct Current Stimulation (tDCS) works by applying a low electrical current to the brain, which can modulate brain activity and potentially reduce cravings and improve self-control. Additionally, combining tDCS with Cognitive Reappraisal Training may enhance cognitive strategies for managing addiction. Unlike traditional treatments, tDCS is non-invasive and could provide a new, accessible way to support recovery in individuals struggling with cocaine addiction.

What evidence suggests that this trial's treatments could be effective for cocaine use disorder?

Research has shown that transcranial direct current stimulation (tDCS) can help reduce cravings in people with cocaine addiction. For example, one study found that repeated tDCS sessions lowered cravings in crack cocaine users. Another study showed that people who received tDCS were less likely to relapse compared to those who received a sham treatment. In this trial, participants may receive either active or sham tDCS. Additionally, Cognitive Reappraisal Training, which teaches people to change how they think about their cravings, has shown promise. This method helps reduce the focus on drug-related triggers, potentially aiding in controlling compulsive cocaine use. Participants in this trial may receive Cognitive Reappraisal Training alongside either active or sham tDCS. Both approaches have potential in helping people with cocaine addiction manage their cravings and reduce drug use.12678

Who Is on the Research Team?

RG

Rita Goldstein, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for inpatients with cocaine use disorder who are seeking treatment. It's designed to see if a non-invasive brain stimulation technique can help reduce their cravings.

Inclusion Criteria

I understand the study and agree to participate.
I am between 18 and 60 years old.
I am using a reliable method of birth control.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex, combined with cognitive reappraisal training or a control condition

5 weeks

Neuroimaging

Neuroimaging is conducted to measure fMRI BOLD signal in the dorsolateral prefrontal cortex before and after tDCS

Conducted at baseline and immediately after 5 weeks of tDCS

Follow-up

Participants are monitored for changes in self-reported craving scores and other outcomes

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Reappraisal Training
  • Transcranial Direct Current Stimulator (tDCS)

Trial Overview

The study tests whether stimulating the brain's dorsolateral prefrontal cortex using tDCS, combined with cognitive reappraisal training, affects craving levels and recovery outcomes in patients with cocaine addiction.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Sham tDCS with Cognitive Reappraisal (CR)Experimental Treatment2 Interventions
Group II: Active tDCS with Cognitive Reappraisal (CR)Experimental Treatment2 Interventions
Group III: Active tDCSExperimental Treatment1 Intervention
Group IV: Sham tDCSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Soterix Medical

Industry Sponsor

Trials
12
Recruited
410+

Citations

A Technique for Regulating Emotion May be Effective in ...

An emotion regulation strategy known as cognitive reappraisal helped reduce the typically heightened and habitual attention to drug-related cues and contexts.

The Predictive Value of Emotion Regulation in Cocaine ...

Traditional treatment approaches in cocaine use disorder (CUD) still report high rates of poor outcomes. Emotion regulation (ER) is a ...

Memory-Focused Cognitive Therapy for Cocaine Use ...

Preliminary evidence that Memory-Focused Cognitive Therapy (MFCT) for cocaine-use disorder can help patients reduce craving and cocaine use.

Memory-focused cognitive therapy for cocaine use disorder

Meta-analysis of cognitive therapy trials for PTSD show that treatment increases the likelihood of PTSD remission when compared to a wait-list control group (14 ...

Comparing the Effectiveness of Reappraisal Strategies in ...

This study evaluates the effectiveness of two cognitive reappraisal strategies-reconstrual (reinterpreting the meaning of an event) and repurposing (modifying ...

Memory-Focused Cognitive Therapy for Cocaine Use ...

Preliminary evidence that Memory-Focused Cognitive Therapy (MFCT) for cocaine-use disorder can help patients reduce craving and cocaine use.

CBT Training for Cognitive Reappraisal as an Intervention ...

The aim of this psychological study is to evaluate the effect of a cognitive behavioral therapy (CBT) intervention aimed at improving cognitive reappraisal ...

Cognitive Reappraisal for Cocaine Use Disorder

Although the current trial phase does not focus on safety data like some ... This makes cognitive reappraisal a potentially safe option for managing cocaine use ...