Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07091877

Cocaine Cue-reactivity Incubation Study

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-).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Muhammad A Parvaz

CONTACT

[email protected]

212-241-3638

Muhammad A Parvaz

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive reappraisal

Behavioral

Cognitive Reappraisal (CR) is a cognitive-behavioral technique and will complete the Cognitive Reappraisal task.

Control cue-reactivity task

Behavioral

Participants will complete a control cue-reactivity task.

Primary outcomes

  1. Change in Late Positive Potential (LPP) amplitude

    Time frame: <2 months, 3 months, and 5 months after abstinence initiation

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

Secondary outcomes

  1. Change in Late Positive Potential (LPP) amplitude with CR

    Time frame: <2 months, 3 months, and 5 months after abstinence initiation

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

  2. Changes in cocaine abstinence duration

    Time frame: <2 months, 3 months, and 5 months after abstinence initiation

    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 contacts

Contact information is provided by the study sponsor or research team.

Muhammad A Parvaz, PhD

CONTACT

[email protected]

212-241-3638

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Cognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.