Cocaine Cue-reactivity Incubation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Reappraisal, Control cue-reactivity task.
- Who it may be relevant to
- Registry conditions: Cocaine Use Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity
Overview
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-).
Interventions
- Behavioral Cognitive Reappraisal
Cognitive Reappraisal (CR) is a cognitive-behavioral technique and will complete the Cognitive Reappraisal task. - Behavioral Control cue-reactivity task
Participants will complete a control cue-reactivity task.
Primary outcome measures
- Change in Late Positive Potential (LPP) amplitude [Time frame: <2 months, 3 months, and 5 months after abstinence initiation]
Secondary outcome measures (2)
- Change in Late Positive Potential (LPP) amplitude with CR [Time frame: <2 months, 3 months, and 5 months after abstinence initiation]
- Changes in cocaine abstinence duration [Time frame: <2 months, 3 months, and 5 months after abstinence initiation]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Icahn School of Medicine at Mount Sinai — New York
Identifiers
NCT: NCT07091877 · STUDY-22-01618 · R01DA058039