A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 6/27/2018 |
Start Date: | May 2015 |
End Date: | June 2018 |
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.
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.
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
We found this trial at
1
site
Lexington, Kentucky
859) 257-9000
Principal Investigator: Craig R Rush, Ph.D.
Phone: 859-257-5388
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
Click here to add this to my saved trials