Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07091877

Cognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-07-29

252

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying individuals with cocaine use disorder (CUD) to understand how brain and behavior responses to cocaine-related cues change over time, especially during abstinence. The study evaluates the effect of a self-regulation technique called Cognitive Reappraisal (CR) on these cue-reactivity responses and explores how these changes relate to clinical outcomes in people recovering from CUD. The research aims to use brain activity and behavioral markers to track these changes over a five-month abstinence period. Participants are randomly assigned to one of two groups: one group practices the Cognitive Reappraisal task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after starting abstinence (CR+ group), while the other group completes a Control cue-reactivity task at the same times (CR- group). The study runs over six months with five sessions in total, including a final session one month after the 5-month visit. Brain activity will be measured using EEG during these sessions to assess responses to the tasks. Participants will attend five study sessions over six months, during which their brain activity and behavior will be evaluated multiple times. The main outcome measured is the change in a brain signal called the Late Positive Potential (LPP) amplitude at various time points after abstinence begins. Researchers will also examine how changes in brain responses relate to the duration of cocaine abstinence and other clinical outcomes. This study is led by the Icahn School of Medicine at Mount Sinai and involves regular assessments to monitor progress and safety.

CONDITIONS

Brief Title

Cocaine Cue-reactivity Incubation Study

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and give informed consent
  • Age 18 to 65 years
  • Diagnosis of cocaine use disorder according to DSM-5
  • Abstinence duration less than 2 months at the first visit
  • Currently seeking treatment for cocaine use disorder at the first visit
Not Eligible

You will not qualify if you...

  • Diagnosis of other psychiatric illnesses except mood and anxiety disorders
  • Positive urine test for psychoactive drugs at baseline
  • History of head trauma with loss of consciousness
  • History of neurological diseases including seizures
  • Thick or non-removable hair braids that interfere with EEG electrode contact

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 5 months after abstinence initiation

Participants complete either the Cognitive Reappraisal task or a control cue-reactivity task at multiple time points after beginning abstinence.

Visits at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation

Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

M

Muhammad A Parvaz, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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