Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
252 participants
INTERVENTIONAL
2024-12-15
2028-08-31
Brief Summary
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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-).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
Cognitive Reappraisal
Cognitive Reappraisal (CR) is a cognitive-behavioral technique and will complete the Cognitive Reappraisal task.
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.
Control cue-reactivity task
Participants will complete a control cue-reactivity task.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Muhammad Parvaz
Associate Professor
Principal Investigators
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Muhammad A Parvaz, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY-22-01618
Identifier Type: -
Identifier Source: org_study_id
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