Clinical trial NCT02444208: A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use
Official title: Randomized Clinical Trial (01): A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stop-Signal Task
timeFrame: 8 weeks after study entry
Secondary outcomes:
measure: Retention
timeFrame: 8, 9 and 10 weeks after study entry
measure: Recruitment
timeFrame: Three years
measure: Treatment acceptability
timeFrame: 8, 9 and 10 weeks after study
measure: Protocol Adherence
timeFrame: Three years
measure: Self-Reported Cocaine Use
timeFrame: 7 days
measure: Biologically verified cocaine use
timeFrame: 72 hours
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Craig R. Rush, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: