NCT03538548

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2014

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

6.8 years

First QC Date

April 27, 2018

Last Update Submit

August 30, 2021

Conditions

Cocaine Use Disorder

Keywords

Cocaine AbuseCocaine Use DisorderSubstance-Related Disorders

Outcome Measures

Primary Outcomes (2)

  • Treatment Engagement

    Number of sessions attended

    12 Weeks

  • Treatment Completion

    Dropout status (completion vs. non-completion)

    12 Weeks

Secondary Outcomes (1)

  • Cocaine Use

    12 Weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Participants receive a standard 12-week course of Cognitive Behavioral Therapy for Relapse Prevention (CBT-RP; Carroll, 1998). The treatment protocol will be implemented over 12 weeks, with two 1-hour sessions per week for the first two weeks and one 1-hour session per week thereafter (i.e., a total of 14 sessions).

Behavioral: CBT-RP

Interventions

CBT-RPBEHAVIORAL

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.

Treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University/New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • Carroll, K. M. (1998). A cognitive behavioral approach: treating cocaine addiction. Rockville, MD: National Institute on Drug Abuse.

    BACKGROUND

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Richard Foltin, Ph.D.

    Columbia University/New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurobiology (in Psychiatry) and Research Scientist VII

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 29, 2018

Study Start

September 30, 2014

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)