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Cognitive Reappraisal Intervention for Cocaine Cue-Reactivity

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Study AimThis basic science study explores the effects of a cognitive reappraisal intervention on cocaine cue-reactivity in adults, measuring changes in Late Positive Potential amplitude with EEG.
What is being tested

Cognitive Reappraisal

+ Control cue-reactivity task
Behavioral
Who is being recruted

Cocaine Use Disorder

From 18 to 65 Years
+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: December 2024

See protocol details

Summary

Principal SponsorIcahn School of Medicine at Mount Sinai
Study ContactMuhammad A Parvaz, PhD
Last updated: July 29, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 15, 2024Actual date on which the first participant was enrolled.

This study focuses on understanding and reducing the response to cocaine-related triggers in individuals with cocaine use disorder (CUD) using a technique called cognitive reappraisal. This technique is a method of self-regulation that helps people change their emotional response to a situation. The aim is to observe how this method affects brain activity and behavior during periods of abstinence from cocaine. Researchers hope that by tracking these changes, they can improve treatment outcomes for people struggling with CUD, potentially offering new ways to help maintain abstinence and reduce relapse rates. Participants in the study will be divided into two groups, with one group practicing cognitive reappraisal and the other completing a control task. They will attend five sessions over six months, with each session involving tasks and brain activity monitoring through EEG tests. These sessions are scheduled at set intervals after the participants begin abstaining from cocaine. 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 for CUD. This approach may provide valuable insights into more effective treatments for cocaine addiction.

Official TitleCognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity 
Principal SponsorIcahn School of Medicine at Mount Sinai
Study ContactMuhammad A Parvaz, PhD
Last updated: July 29, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
252 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cocaine Use Disorder
Criteria
5 inclusion criteria required to participate
Ability to understand and give informed consent
Age 18-65
DSM-5 Diagnosis of CUD (Cocaine Use Disorder)
Have appropriate abstinence duration (i.e., <2 months) at the first visit

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5 exclusion criteria prevent from participating
DSM-5 diagnosis for other psychiatric illnesses (other than mood and anxiety disorders that are highly comorbid with substance use disorders)
Urine positive for any psychoactive drugs (e.g., cocaine, methamphetamine, cannabis, opiates, benzodiazepines, etc.) at baseline
Head trauma with loss of consciousness
History of neurological diseases, including seizures

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
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
Sham
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.
Study Objectives
Primary Objectives

EEG-derived Late Positive Potential (LPP) amplitude will be measured while participants view cocaine-related cues. Higher amplitudes indicate greater cue reactivity.
Secondary Objectives

EEG-derived Late Positive Potential (LPP) amplitude changes during cocaine cue exposure while using cognitive reappraisal techniques.

Cocaine abstinence (measured in number of days) will be assessed via Timeline Followback Calendar, which tabulates the number of days cocaine was used in the past 90 days.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
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Icahn School of Medicine at Mount SinaiNew York, United StatesSee the location
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One Study Center