Clinical trial NCT02174614: The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)
Official title: The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Use Disorder
Keywords: Cocaine use disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-06-25
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Reduction in cocaine use
timeFrame: 12 weeks
Secondary outcomes:
measure: Subjects ability to demonstrate coping skills acquisition through a computerized role-playing evaluation
timeFrame: 12 weeks
Other outcomes:
measure: Increased cognitive function and working memory
timeFrame: 12 weeks
Locations:
city: Bridgeport
country: United States
facility: MCCA
state: Connecticut
city: New Haven
country: United States
facility: MCCA
state: Connecticut
Study officials:
affiliation: Yale University
name: Brian Kiluk, PhD
role: STUDY_DIRECTOR
References: