A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-06-30

Brief Summary

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Cocaine abuse is an unrelenting public-health concern. Behavioral therapies are considered the "standard of care" for reducing cocaine use and preventing relapse. However, even with intense behavioral interventions, rates of relapse to cocaine use are discouragingly high (i.e., 60-95% of patients return to drug use). Novel strategies are urgently needed to improve treatment outcomes for cocaine-use disorders. The overarching goal of this project is to assess the feasibility, acceptability and initial efficacy of an innovative cocaine-based inhibitory-control training procedure. This goal will be accomplished through the conduct of a Stage I pilot trial. Cocaine-dependent participants will be enrolled and randomized to receive inhibitory-control training to cocaine or neutral images (N=20/condition). This proposed intervention, cocaine based inhibitory-control training, will be delivered using an innovative computer program which teaches cocaine abusers to inhibit a pre-potent response to cocaine or neutral cues. The primary hypothesis is the proposed procedures are feasible and acceptable to the participants. Feasibility will be assessed by determining time needed to enroll the target sample; adaptive randomization outcomes; participant attendance, completion and adherence to study procedures. Acceptability will be determined using a Treatment Acceptability Questionnaire. The secondary hypothesis is that participants receiving cocaine-based inhibitory-control training will reduce their drug use to a greater extent than their counterparts in the neutral-image condition. Reduced cocaine use will be demonstrated by fewer positive-urine samples using qualitative urinalysis and a reduction in levels of benzoylecgonine as determined by quantitative urinalysis (i.e., ELISA). The third hypothesis is that participants receiving cocaine-based inhibitory-control training will show improved inhibitory control and neurocognitive functioning relative to their counterparts in the neutral-image condition. Improved inhibitory control, impulsivity and cognitive functioning will be demonstrated using a battery of clinical instruments and laboratory tasks. The proposed research is highly innovative in that it will provide critical information regarding the feasibility, acceptability, initial efficacy of cocaine-based inhibitory-control training to reduce drug use and improve inhibitory control and neurocognitive functioning in cocaine-dependent participants. Cocaine-based inhibitory control training is also easy to administer (i.e., 15 minutes), inexpensive, need not be administered by a clinician, and could easily be incorporated into current behavioral or community-based treatment approaches to enhance sustained abstinence, thereby quickly impacting clinical research and practice.

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Detailed Description

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Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cocaine Inhibitory Control Training

This group will receive active inhibitory control training.

Group Type EXPERIMENTAL

Active Inhibitory Control Training

Intervention Type BEHAVIORAL

Subjects will learn to inhibit responding in the presence of cocaine cues.

Neutral Inhibitory Control Training

This group will receive neutral inhibitory control training.

Group Type PLACEBO_COMPARATOR

Neutral Inhibitory Control Training

Intervention Type BEHAVIORAL

Subjects will learn to inhibit responding in the presence of neutral cues.

Interventions

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Active Inhibitory Control Training

Subjects will learn to inhibit responding in the presence of cocaine cues.

Intervention Type BEHAVIORAL

Neutral Inhibitory Control Training

Subjects will learn to inhibit responding in the presence of neutral cues.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Recent cocaine use verified by a cocaine-positive urine sample
* Meet Cocaine Abuse or Dependence criteria, verified by computerized Structured Clinical Interview for DSM-IV (SCID)
* Subjects must be seeking treatment for their cocaine use.
* Subjects must have at least 10% errors in response to cocaine go cues on the ABBA Task at baseline

Exclusion Criteria

* History of serious physical or psychiatric disease that would interfere with study participation
* Current physical or psychiatric disease that would interfere with study participation
* Current or past histories of substance abuse or dependence that would interfere with study completion

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes