Cocaine Cue-reactivity Incubation Study

Cognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity

In this study, the research team proposes to longitudinally assess incubation of cue-reactivity, its reduction with cognitive reappraisal (CR; a self-regulation technique) and examine the impact of CR on clinical outcomes in individuals with cocaine use disorder (CUD). The primary objective is to use psychophysiological markers for tracking brain activity and behavior and changes therein with the use of CR during abstinence in CUD. The secondary objective is to examine whether brain and behavioral changes are associated with clinical outcomes in individuals with CUD. The primary endpoint is the time-related change in brain and behavioral indices with CR during abstinence in individuals with CUD. The secondary endpoint is the impact of CR-mediated changes on clinical outcomes of individuals with CUD.

In this 5-yearlong study the research team will recruit 252 individuals seeking-treatment for CUD, 126 of whom will be randomly assigned to complete the Cognitive Reappraisal task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation (CR+ group), and the other 126 will be assigned to complete a Control task at the same time points (CR- group). All individuals between the ages of 18 and 65 years, irrespective of sex and sexual orientation will be recruited. Participation in the research study will be 5 sessions taking place (one at 2 weeks from screening, one at a month from screening, one at 3 months from screening, one at 5 months from screening, and one the month after the 5 month session) over the course of 6 months.

The study will include EEG testing and will be administered multiple times over the course of 6 months. Participants will be randomized to one of the two groups; one group will get the Cognitive Reappraisal (CR+) intervention and the other group will get a Control intervention (CR-).

Study Overview

• Status: Recruiting
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Behavioral: Cognitive Reappraisal; Behavioral: Control cue-reactivity task

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad A Parvaz, PhD; Phone Number: 212-241-3638; Email: muhammad.parvaz@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Muhammad A Parvaz; Phone Number: 212-241-3638; Email: muhammad.parvaz@mssm.edu
      • Principal Investigator: Muhammad A Parvaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Must be seeking treatment for CUD (at the first visit)

Exclusion Criteria:

• 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
• Thick and/or non-removable hair braids that present difficulty for EEG electrode-scalp contact

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Reappraisal (CR+); 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.	Behavioral: Cognitive Reappraisal; Cognitive Reappraisal (CR) is a cognitive-behavioral technique and will complete the Cognitive Reappraisal task.
Sham Comparator: No Cognitive Reappraisal (CR-); 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.	Behavioral: Control cue-reactivity task; Participants will complete a control cue-reactivity task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Late Positive Potential (LPP) amplitude	EEG-derived Late Positive Potential (LPP) amplitude will be measured while participants view cocaine-related cues. Higher amplitudes indicate greater cue reactivity.	<2 months, 3 months, and 5 months after abstinence initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Late Positive Potential (LPP) amplitude with CR	EEG-derived Late Positive Potential (LPP) amplitude changes during cocaine cue exposure while using cognitive reappraisal techniques.	<2 months, 3 months, and 5 months after abstinence initiation
Changes in cocaine abstinence duration	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.	<2 months, 3 months, and 5 months after abstinence initiation

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Muhammad A Parvaz, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: July 21, 2025
• First Submitted That Met QC Criteria: July 21, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: EEG; Cocaine; Craving; Cue-reactivity; Incubation; Cognitive reappraisal
• Other Study ID Numbers: STUDY-22-01618; R01DA058039 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Anyone who wishes to access the data. For individual participant data meta-analysis. Data are available indefinitely at URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No