A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use
Condition: Cocaine Use Disorder
Study type: Interventional

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.
    


Intervention name(s): Active Inhibitory Control Training; Neutral Inhibitory Control Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will learn to inhibit responding in the presence of cocaine cues.; Subjects will learn to inhibit responding in the presence of neutral cues.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment