Cue-reactivity incubation and cognitive reappraisal in cocaine use disorder
Cognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity
NA · Icahn School of Medicine at Mount Sinai · NCT07091877
This project will see if practicing cognitive reappraisal reduces cue-triggered brain responses and cravings in people with cocaine use disorder who are early in abstinence.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07091877 on ClinicalTrials.gov |
What this trial studies
This 5-year longitudinal study will enroll 252 treatment-seeking adults (age 18–65) with DSM-5 cocaine use disorder and will track cue-reactivity using EEG and behavioral markers during early abstinence. Approximately 126 participants will be randomly assigned to repeated cognitive reappraisal tasks while the remainder complete a control cue-reactivity task, with repeated visits to measure change over time. The primary endpoints are time-related changes in brain and behavioral indices with cognitive reappraisal during abstinence, and secondary analyses will examine whether those changes relate to clinical outcomes such as craving and relapse. Testing and EEG sessions will be conducted in person at Icahn School of Medicine at Mount Sinai in New York City.
Who should consider this trial
Good fit: Ideal candidates are treatment-seeking adults (18–65) with DSM-5 cocaine use disorder who are in early abstinence (<2 months) and are able to complete EEG-based testing and cognitive tasks.
Not a fit: People with recent positive urine drug screens, uncontrolled or disqualifying psychiatric or neurological disorders, or who cannot undergo EEG (for example due to non-removable hair styles preventing electrode contact) may not benefit or be eligible.
Why it matters
Potential benefit: If successful, cognitive reappraisal could reduce cue-driven cravings and dampen brain responses to cocaine cues, potentially lowering relapse risk.
How similar studies have performed: Prior laboratory and small clinical studies have shown that cognitive reappraisal can reduce cue-elicited craving and alter EEG/fMRI signals in substance use disorders, but large longitudinal randomized evidence specifically in cocaine use disorder is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Muhammad A Parvaz, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Muhammad A Parvaz, PhD
- Email: muhammad.parvaz@mssm.edu
- Phone: 212-241-3638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cocaine Use Disorder, Cocaine, Craving, EEG, Cue-reactivity, Cognitive reappraisal, Incubation