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

NCT ID: NCT02174614

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Treatment As Usual (TAU)

Intervention Type 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)

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

Group Type EXPERIMENTAL

Treatment As Usual (TAU)

Intervention Type 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)

Intervention Type 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)

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.

Group Type EXPERIMENTAL

Treatment As Usual (TAU)

Intervention Type 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)

Intervention Type 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)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Kiluk, PhD

Role: STUDY_DIRECTOR

Yale University

Locations

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MCCA

Bridgeport, Connecticut, United States

Site Status

MCCA

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2P50DA009241-21

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1405013937

Identifier Type: -

Identifier Source: org_study_id

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