Actively Recruiting
Cocaine Cue-reactivity Incubation Study
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-07-29
252
Participants Needed
1
Research Sites
193 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
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
Official Title
Cocaine Cue-reactivity Incubation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and give informed consent
- Age 18-65
- DSM-5 diagnosis of cocaine use disorder
- Abstinence duration less than 2 months at first visit
- Seeking treatment for cocaine use disorder at first visit
You will not qualify if you...
- DSM-5 diagnosis of other psychiatric illnesses (except mood and anxiety disorders comorbid with substance use 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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Muhammad A Parvaz, PhD
CONTACT
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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