Cognitive Reappraisal Intervention for Cocaine Cue-Reactivity
This basic science study explores the effects of a cognitive reappraisal intervention on cocaine cue-reactivity in adults, measuring changes in Late Positive Potential amplitude with EEG.
Cognitive Reappraisal
+ Control cue-reactivity task
Basic Science Study
Summary
Study start date: December 15, 2024
Actual date on which the first participant was enrolled.This study focuses on understanding and reducing the response to cocaine-related triggers in individuals with cocaine use disorder (CUD) using a technique called cognitive reappraisal. This technique is a method of self-regulation that helps people change their emotional response to a situation. The aim is to observe how this method affects brain activity and behavior during periods of abstinence from cocaine. Researchers hope that by tracking these changes, they can improve treatment outcomes for people struggling with CUD, potentially offering new ways to help maintain abstinence and reduce relapse rates. Participants in the study will be divided into two groups, with one group practicing cognitive reappraisal and the other completing a control task. They will attend five sessions over six months, with each session involving tasks and brain activity monitoring through EEG tests. These sessions are scheduled at set intervals after the participants begin abstaining from cocaine. The study will measure changes in brain activity and behavior over time and assess whether these changes lead to better clinical outcomes for those in treatment for CUD. This approach may provide valuable insights into more effective treatments for cocaine addiction.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.252 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location