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

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.

Study Overview

• Status: Completed
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Behavioral: Treatment As Usual (TAU); Behavioral: TAU plus Rapid Abstinence Initiation (RAI); Behavioral: TAU plus RAI plus Cognitive Control Training (CCT)

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06601
      • MCCA
    • New Haven, Connecticut, United States, 06511
      • MCCA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in cocaine use	Using urine and breathalyzer screening for negative cocaine and alcohol testing.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects ability to demonstrate coping skills acquisition through a computerized role-playing evaluation	Use of CBT4CBT program with acquisition of skills demonstrated through homework assignments.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased cognitive function and working memory	development of skills used in attention, working memory and inhibitory control as demonstrated through an extensive assessment battery.	12 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Study Director: Brian Kiluk, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Cocaine use disorder
• Other Study ID Numbers: 1405013937; 2P50DA009241-21 (U.S. NIH Grant/Contract)