Cocaine Cue-reactivity Incubation Study

NCT07091877 | Recruiting

• 2 other identifiers: STUDY-22-01618R01DA058039
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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-).

Conditions

Cocaine Use Disorder

Keywords

Cocaine; Craving; EEG; Cue-reactivity; Cognitive reappraisal; Incubation

Outcome Measures

Primary Outcomes (1)

• Change in Late Positive Potential (LPP) amplitude

  EEG-derived Late Positive Potential (LPP) amplitude will be measured while participants view cocaine-related cues. Higher amplitudes indicate greater cue reactivity.

  <2 months, 3 months, and 5 months after abstinence initiation

Secondary Outcomes (2)

• Change in Late Positive Potential (LPP) amplitude with CR

  <2 months, 3 months, and 5 months after abstinence initiation

• Changes in cocaine abstinence duration

  <2 months, 3 months, and 5 months after abstinence initiation

Study Arms (2)

Cognitive Reappraisal (CR+)

EXPERIMENTAL

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.

Behavioral: Cognitive Reappraisal

No Cognitive Reappraisal (CR-)

SHAM COMPARATOR

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.

Behavioral: Control cue-reactivity task

Interventions

Cognitive Reappraisal BEHAVIORAL

Cognitive Reappraisal (CR) is a cognitive-behavioral technique and will complete the Cognitive Reappraisal task.

Cognitive Reappraisal (CR+)

Control cue-reactivity task BEHAVIORAL

Participants will complete a control cue-reactivity task.

No Cognitive Reappraisal (CR-)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Study Officials

• Muhammad A Parvaz, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad A Parvaz, PhD

CONTACT

212-241-3638; muhammad.parvaz@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: December 15, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Anyone who wishes to access the data. For individual participant data meta-analysis. Data are available indefinitely at URL below.

Locations

US (1)