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OpenTrials
Completed

NCT Number: NCT03538548

Treatment Outcome in CBT for Cocaine Use

Cognitive-behavioral treatments for cocaine abuse could be improved by an increased understanding of factors that predict treatment outcomes. The objective of this protocol is to conduct a study examining the impact of client characteristics on the effects of cognitive-behavioral therapy for cocaine abuse.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University/New York State Psychiatric Institute

New York, 10032, United States

About this study

Study investigators will recruit treatment-seeking cocaine users (n = 100) from a separate protocol (#6912) who will receive a standard 12-week course of cognitive behavioral therapy for relapse prevention. Using a variety of self-report questionnaires and computer-based tasks, three major domains will be assessed and evaluated as predictors of treatment outcome: (1) impulsivity, (2) motivation to change, and (3) learning style. Measures of these factors will have been obtained in the #6912 protocol. A better understanding of the impact of impulsivity, motivation to change, and learning style on treatment outcome will provide critical information to guide the refinement of CBT for cocaine abuse. For example, the results of this study may help guide the development and introduction of more targeted cognitive remedial strategies or behavioral training components into the framework of evidenced-based practices. These additions may help ameliorate the deleterious effects of specific participant characteristics on the acquisition and implementation of coping skills, which can further improve the efficacy of CBT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals age 18-60.
  • Currently report using cocaine via the intranasal or smoked route.
  • Be able to give informed consent and comply with study procedures.

Exclusion criteria

  • Individuals who meet current (i.e., within the past year) DSM-5 severe Substance Use Disorder (SUD) criteria (defined as the presence of 6 or more symptoms) for drugs other than cocaine, nicotine and caffeine.
  • Individuals who meet current (i.e., within the past year) DSM-5 moderate to severe Major Depressive Disorder criteria (defined as a score of 17 or higher on the Hamilton Depression Rating Scale).
  • Individuals who meet current DSM-5 criteria for any bipolar or psychotic disorder (other than transient psychosis due to drug use), or for all other psychiatric disorders not addressed by other exclusion criteria (e.g., anxiety disorders other than specific phobias, eating disorders, or ADHD) that require medical and/or psychological intervention.
  • Individuals with a neurodevelopmental disorder (e.g., Intellectual Development Disorder, Autism Spectrum Disorder) except ADHD.
  • Individuals with uncorrected visual or auditory deficits, or who cannot adequately read or understand the self-report assessment forms, or are so severely disabled they cannot comply with the requirements of the study.
  • Individuals with current suicidal risk.
  • Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.
  • Individuals who are currently receiving any professional treatment (e.g., therapy, medication) for substance abuse problems outside of the current research protocol.

Treatment and study plan

CBT-RP

Behavioral

CBT-RP is a time-limited, manual guided intervention that aims to develop behavioral and cognitive skills needed to initiate abstinence and prevent relapse. The treatment will help individuals analyze the decision making process to minimize the influence of more immediate reinforcement, develop cognitive strategies to promote the attainment of longer-term goals, practice behavioral strategies to reduce the influence of socially mediated threats to abstinence, and outline explicit plans for managing situations that threaten their goal of abstinence.

Primary outcomes

  1. Treatment Engagement

    Time frame: 12 Weeks

    Number of sessions attended

  2. Treatment Completion

    Time frame: 12 Weeks

    Dropout status (completion vs. non-completion)

Secondary outcomes

  1. Cocaine Use

    Time frame: 12 Weeks

    Number of weeks of self-reported abstinence (verified by negative urinary drug screen)

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Predictors of Treatment Outcome in Cognitive-Behavioral Therapy for Cocaine Use

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
May 29, 2018
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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