A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use (RCT(01))

Randomized Clinical Trial (01): A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use

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.

Study Overview

• Status: Completed
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Behavioral: Active Inhibitory Control Training; Behavioral: Neutral Inhibitory Control Training

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40507
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cocaine Inhibitory Control Training; This group will receive active inhibitory control training.	Behavioral: Active Inhibitory Control Training; Subjects will learn to inhibit responding in the presence of cocaine cues.
Placebo Comparator: Neutral Inhibitory Control Training; This group will receive neutral inhibitory control training.	Behavioral: Neutral Inhibitory Control Training; Subjects will learn to inhibit responding in the presence of neutral cues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stop-Signal Task	Response inhibition and response execution will be measured using a stop-signal paradigm using a choice reaction time task that engages participants in responding to go-signals when stop-signals occasionally inform them to inhibit the response.	8 weeks after study entry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	The number of subjects retained through follow up will be determined.	8, 9 and 10 weeks after study entry
Recruitment	The number of subjects recruited into the entire trial will be determined.	Three years
Treatment acceptability	A patient treatment acceptability questionnaire will be included to determine whether patients find study procedures acceptable.	8, 9 and 10 weeks after study
Protocol Adherence	The number of protocol violations across the entire trial will be determined.	Three years
Self-Reported Cocaine Use	Self-reported cocaine use will be recorded every 7 days for 10 weeks.	7 days
Biologically verified cocaine use	Cocaine use will be determined using quantitative and qualitative screens at least every 72 hours for 8 weeks.	72 hours

Collaborators and Investigators

• Sponsor: University of Kentucky
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Craig R. Rush, Ph.D., University of Kentucky

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: RCT (01); R34DA038869 (U.S. NIH Grant/Contract)