Cocaine Use Disorder
Conditions
Keywords
Cocaine, Craving, EEG, Cue-reactivity, Cognitive reappraisal, Incubation
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-).
Interventions
BEHAVIORALCognitive Reappraisal
Cognitive Reappraisal (CR) is a cognitive-behavioral technique and will complete the Cognitive Reappraisal task.
BEHAVIORALControl cue-reactivity task
Participants will complete a control cue-reactivity task.
Sponsors
National Institute on Drug Abuse (NIDA)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Late Positive Potential (LPP) amplitude | <2 months, 3 months, and 5 months after abstinence initiation | EEG-derived Late Positive Potential (LPP) amplitude will be measured while participants view cocaine-related cues. Higher amplitudes indicate greater cue reactivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Late Positive Potential (LPP) amplitude with CR | <2 months, 3 months, and 5 months after abstinence initiation | EEG-derived Late Positive Potential (LPP) amplitude changes during cocaine cue exposure while using cognitive reappraisal techniques. |
| Changes in cocaine abstinence duration | <2 months, 3 months, and 5 months after abstinence initiation | Cocaine abstinence (measured in number of days) will be assessed via Timeline Followback Calendar, which tabulates the number of days cocaine was used in the past 90 days. |
Countries
United States
Contacts
Primary ContactMuhammad A Parvaz, PhD
Outcome results
None listed