Recruiting

Cognitive Reappraisal

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07091877

Conditions

Cocaine Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive Reappraisal

Control cue-reactivity task

Study Details

Brief 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

Cocaine Use Disorder

Study ID

NCT07091877

Start date

Dec 15, 2024

Status verified date

Dec, 2024

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Cognitive Reappraisal

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

Control cue-reactivity task

Participants will complete a control cue-reactivity task.

Primary outcome measure

  • Change in Late Positive Potential (LPP) amplitude [ Time Frame: <2 months, 3 months, and 5 months after abstinence initiation ]

Central Contacts and Locations

Central contacts

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Muhammad A Parvaz

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 29, 2025

Last verified

Dec, 2024

Keywords

  • Cocaine
  • Craving
  • EEG
  • Cue-reactivity
  • Cognitive reappraisal
  • Incubation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-07-29.