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

NCT02444208 | Completed DMC

• 2 other identifiers: RCT (01)R34DA038869
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Retention

  8, 9 and 10 weeks after study entry

• Recruitment

  Three years

• Treatment acceptability

  8, 9 and 10 weeks after study

• Protocol Adherence

  Three years

• Self-Reported Cocaine Use

  7 days

Study Arms (2)

Cocaine Inhibitory Control Training

EXPERIMENTAL

This group will receive active inhibitory control training.

Behavioral: Active Inhibitory Control Training

Neutral Inhibitory Control Training

PLACEBO COMPARATOR

This group will receive neutral inhibitory control training.

Behavioral: Neutral Inhibitory Control Training

Interventions

Active Inhibitory Control Training BEHAVIORAL

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

Cocaine Inhibitory Control Training

Neutral Inhibitory Control Training BEHAVIORAL

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

Neutral Inhibitory Control Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40507, United States

Location

Study Officials

• Craig R. Rush, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 14, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

US (1)