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Completed

NCT Number: NCT02174614

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

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.

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Key information

Conditions

Cocaine Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MCCA, Bridgeport, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Treatment as Usual (TAU)

Behavioral

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)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Reduction in cocaine use

    Time frame: 12 weeks

    Using urine and breathalyzer screening for negative cocaine and alcohol testing.

Secondary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: Project 1

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2014
Registry last updated
Oct 14, 2020

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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