Cognitive Reappraisal for Cocaine Use Disorder

Overseen By Muhammad A Parvaz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Psychoactive drugs

Disqualifiers: Other psychiatric illnesses, Neurological diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a technique called Cognitive Reappraisal, a self-regulation method, to determine if it can help individuals with cocaine use disorder (CUD) manage their response to triggers and improve outcomes during abstinence. Researchers aim to track changes in brain activity and behavior to understand how this technique works. Participants will be divided into two groups: one will use the Cognitive Reappraisal method, and the other will engage in a control cue-reactivity task. The trial seeks individuals actively seeking treatment for CUD who have been abstinent for less than two months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment strategies for CUD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this self-regulation technique is safe for individuals with cocaine use disorder?

Earlier studies have shown that cognitive reappraisal holds promise for individuals with cocaine use disorder. Research indicates that this technique, which aids in managing emotions, can reduce attention to drug-related triggers that often cause cravings. It works by teaching individuals to change their thoughts about situations that prompt drug use.

No serious side effects have been reported from using cognitive reappraisal, suggesting it is generally well-tolerated. Although the current trial phase does not focus on safety data like some other trials, the absence of reported negative effects in previous research is reassuring. This makes cognitive reappraisal a potentially safe option for managing cocaine use disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Reappraisal for treating cocaine use disorder because it offers a novel approach that focuses on changing thought patterns rather than relying on medication. Unlike current treatments that often involve medication-assisted therapies targeting brain chemistry, Cognitive Reappraisal seeks to empower individuals to reinterpret their cravings and emotional responses. This method could potentially provide a non-pharmacological option that reduces reliance on medications and enhances long-term recovery by addressing the cognitive processes underlying addiction.

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

Research has shown that cognitive reappraisal, a method of managing emotions by changing thoughts about a situation, can aid individuals with cocaine use disorder. In this trial, participants in the Cognitive Reappraisal (CR+) arm will repeatedly complete this task at specified intervals. Studies indicate that this technique reduces the strong focus on drug-related triggers, common in addiction. By altering the brain's response to these triggers, cognitive reappraisal may improve treatment outcomes. It helps individuals in treatment experience fewer cravings and potentially remain drug-free longer. Evidence supports that managing emotions plays a significant role in overcoming addiction. ^{2 4 6 7 8}

Who Is on the Research Team?

Muhammad A Parvaz, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-65 with Cocaine Use Disorder (CUD) who are seeking treatment and have been abstinent for less than 2 months. Participants must understand the study and consent to join. The trial excludes certain people based on criteria not specified here.

Inclusion Criteria

I have been diagnosed with Cocaine Use Disorder.

I have not had sexual activity for less than 2 months.

I understand the study and agree to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants are assigned to either the Cognitive Reappraisal (CR+) or Control (CR-) group and complete tasks at specified intervals

6 months

5 visits (in-person)

Follow-up

Participants are monitored for changes in brain and behavioral indices and clinical outcomes

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Reappraisal
• Control cue-reactivity task

Trial Overview The study tests if Cognitive Reappraisal (CR), a self-regulation technique, can reduce cue-reactivity and improve clinical outcomes in CUD patients. It compares CR against a control task over five sessions spanning six months, using EEGs to track brain activity changes.

How Is the Trial Designed?

Group I: Cognitive Reappraisal (CR+) Experimental Treatment 1 Intervention

Participants in this arm will complete the Cognitive Reappraisal task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation.

Group II: No Cognitive Reappraisal (CR-) Placebo Group 1 Intervention

Participants in this arm will complete a control cue-reactivity task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8201879/

Attention bias modification in drug addiction This study assessed whether habitual (drug-related) attentional processes can be disrupted by cognitive reappraisal, an adaptive emotion regulation strategy.

2. mountsinai.org mountsinai.org/about/newsroom/2021/a-technique-for-regulating-emotion-may-be-effective-in-disrupting-compulsive-cocaine-addiction

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.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/cpp.70155

The Predictive Value of Emotion Regulation in Cocaine ... This study explores whether ER difficulties at treatment entry predict addiction severity and withdrawal symptom severity after discharge in ...

4. patlynk.com patlynk.com/trial/NCT07091877

Cognitive Reappraisal Intervention for Cocaine Cue ... The study will measure changes in brain activity and behavior over time and assess whether these changes lead to better clinical outcomes for those in treatment ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5367621/

Emotion regulation strategies in individuals with cocaine ... In sum, both CR and ES scores were comparable to undergraduates', but CR was associated with fewer depressive symptoms. Researchers should continue to examine ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12453906/

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 ...

7. thelancet.com thelancet.com/article/S2352-3964(18)30043-4/fulltext

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.

8. nature.com nature.com/articles/s41398-024-03159-5

Addiction: Emotional Dysregulation Drives Relapse to Drug Use These results suggest that people with cocaine dependence demonstrate increased sensitisation to negative emotions compared with controls and ...