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NCT07091877 · ClinicalTrials.gov registry record · NA

Cocaine Cue-reactivity Incubation Study

A NA study of Cocaine Use Disorder, sponsored by Icahn School of Medicine at Mount Sinai.

Recruiting
Registry status
NA
Development phase
252
Enrollment target
1
Study location

NCT07091877 is a NA study of Cocaine Use Disorder that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 252 participants, above the 94-participant average among 26 other Cocaine Use Disorder trials with a reported enrollment target (168% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT07091877, a NA study of Cocaine Use Disorder, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.

RECRUITING
Registry status
NA
Development phase
252 participants
Enrollment target
1
Study location

Study Summary

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-).

Conditions Studied

Cocaine Use Disorder

Interventions

  • BEHAVIORAL Cognitive Reappraisal
  • BEHAVIORAL Control cue-reactivity task

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 252 participants
Start Date 2024-12-15
Est. Completion 2028-08-31
Phase NA

Sponsor

Icahn School of Medicine at Mount Sinai

708 total trials

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What the Registry Record Tells You About NCT07091877

The ClinicalTrials.gov registry entry for NCT07091877 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 94-participant average among 26 other Cocaine Use Disorder trials with a reported enrollment target (168% higher). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cocaine Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Reappraisal is the first listed.

NCT07091877 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT07091877 about?

NCT07091877 is a clinical study titled "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 us...

What is the current status of trial NCT07091877?

This trial is currently recruiting. It is a NA study. The enrollment target is 252 participants. The study started on 2024-12-15. Estimated completion is 2028-08-31.

What conditions does trial NCT07091877 study?

This clinical trial studies the following conditions: Cocaine Use Disorder.

What interventions are being tested in trial NCT07091877?

The interventions under investigation include: Cognitive Reappraisal (BEHAVIORAL), Control cue-reactivity task (BEHAVIORAL).

Who is sponsoring clinical trial NCT07091877?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07091877 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.