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The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) (Project 1)

This study is currently recruiting participants.
Verified September 2017 by Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02174614
First Posted: June 25, 2014
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  Purpose
The investigators are conducting a randomized clinical trial of rapid abstinence initiation and cognitive control training as a precursor to our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program to evaluate its effectiveness relative to standard outpatient counseling at the Midwestern Connecticut Council of Alcoholism (MCCA). CCT will be used to assess attention, working memory and inhibitory control and the computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving cocaine abuse treatment.

Condition Intervention Phase
Cocaine Use Disorder Behavioral: Treatment As Usual (TAU) Behavioral: TAU plus Rapid Abstinence Initiation (RAI) Behavioral: TAU plus RAI plus Cognitive Control Training (CCT) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Reduction in cocaine use [ Time Frame: 12 weeks ]
    Using urine and breathalyzer screening for negative cocaine and alcohol testing.


Secondary Outcome Measures:
  • Subjects ability to demonstrate coping skills acquisition through a computerized role-playing evaluation [ Time Frame: 12 weeks ]
    Use of CBT4CBT program with acquisition of skills demonstrated through homework assignments.


Other Outcome Measures:
  • Increased cognitive function and working memory [ Time Frame: 12 weeks ]
    development of skills used in attention, working memory and inhibitory control as demonstrated through an extensive assessment battery.


Estimated Enrollment: 150
Study Start Date: April 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment As Usual (TAU)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time.
Behavioral: Treatment As Usual (TAU)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time.
Experimental: TAU plus Rapid Abstinence Initiation (RAI)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment
Behavioral: Treatment As Usual (TAU)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time.
Behavioral: TAU plus Rapid Abstinence Initiation (RAI)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment followed by 8 weeks of CBT4CBT computerized therapy.
Experimental: TAU plus RAI plus Cognitive Control Training (CCT)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized games 3 times per week for the first 4 weeks.
Behavioral: Treatment As Usual (TAU)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time.
Behavioral: TAU plus Rapid Abstinence Initiation (RAI)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment followed by 8 weeks of CBT4CBT computerized therapy.
Behavioral: TAU plus RAI plus Cognitive Control Training (CCT)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized cognitive control training (CCT) 3 times per week for the first 4 weeks followed by 8 weeks of CBT4CBT computerized therapy.

Detailed Description:
150 cocaine dependent individuals will be randomly assigned to one of 3 conditions delivered over 4 weeks in the context of intensive outpatient treatment. 1. Treatment as Usual (TAU), 2. rapid abstinence initiation (RAI) or 3. computerized cognitive control training with escalating reinforcement for improved performance on training tasks (CCT). All participants will then receive an 8 week trial of CBT4CBT in addition to TAU. Follow up evaluation thru 6 months posttreatment will assess durability and delayed emergence of treatment effects.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Meet current DSM-5 criteria for cocaine use disorder
  • Are sufficiently stable for 12 weeks of outpatient treatment
  • Are willing to provide locator information for follow-up
  • Are fluent in English
  • Have a 6th grade or higher reading level for completion of assessments

Exclusion Criteria:

  • Untreated bipolar or schizophrenic disorder
  • Current suicide risk
  • Have a legal case pending such that incarceration during the 12-week protocol is likely
  • Are physically dependent on alcohol, opioids or benzodiazepines and require detoxification
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174614


Contacts
Contact: Liz Doohan, BA 203-285-6475 ext 2506 elizabeth.doohan@yale.edu

Locations
United States, Connecticut
RCS Recruiting
Bridgeport, Connecticut, United States, 06601
Contact: Lawanda Frederick, MSW       lawanda.frederick@yale.edu   
Sub-Investigator: Brian Kiluk, PhD         
Sponsors and Collaborators
Yale University
Investigators
Study Director: Brian Kiluk, PhD Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02174614     History of Changes
Other Study ID Numbers: 14050 13937
First Submitted: June 23, 2014
First Posted: June 25, 2014
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Yale University:
Cocaine use disorder

Additional relevant MeSH terms:
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents