Cocaine Cue-reactivity Incubation Study

Mount Sinai Health System

Status: Enrolling

Conditions: Cocaine Use Disorder

Treatments: Behavioral: Control cue-reactivity task; Behavioral: Cognitive Reappraisal

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07091877

R01DA058039 (U.S. NIH Grant/Contract)

STUDY-22-01618

Details and patient eligibility

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-).

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

Cognitive Reappraisal (CR+)

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Reappraisal

No Cognitive Reappraisal (CR-)

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Control cue-reactivity task