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

Cocaine Use Disorder Clinical Trial

— Project 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174614
• Other study ID #: 1405013937
• Secondary ID: 2P50DA009241-21
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	MCCA	Bridgeport	Connecticut
United States	MCCA	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Reduction in cocaine use	Using urine and breathalyzer screening for negative cocaine and alcohol testing.	12 weeks
Secondary	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