Cocaine Use DisorderRCT(01)NCT02444208
A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use
A study of Cocaine Use Disorder, run by University of Kentucky at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cocaine Use Disorder
- Being tested
- Active Inhibitory Control Training, Neutral Inhibitory Control Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Inhibitory Control TrainingBehavioural
Subjects will learn to inhibit responding in the presence of cocaine cues.
Neutral Inhibitory Control TrainingBehavioural
Subjects will learn to inhibit responding in the presence of neutral cues.
| Study group | Role | What they receive |
|---|---|---|
| Cocaine Inhibitory Control Training | Experimental | This group will receive active inhibitory control training. Receives: Behavioral: Active Inhibitory Control Training |
| Neutral Inhibitory Control Training | Placebo comparator | This group will receive neutral inhibitory control training. Receives: Behavioral: Neutral Inhibitory Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks after study entry
Secondary outcomes (6)
Retention
The number of subjects retained through follow up will be determined.
Measured: 8, 9 and 10 weeks after study entry
Recruitment
The number of subjects recruited into the entire trial will be determined.
Measured: Three years
Treatment acceptability
A patient treatment acceptability questionnaire will be included to determine whether patients find study procedures acceptable.
Measured: 8, 9 and 10 weeks after study
Protocol Adherence
The number of protocol violations across the entire trial will be determined.
Measured: Three years
Self-Reported Cocaine Use
Self-reported cocaine use will be recorded every 7 days for 10 weeks.
Measured: 7 days
Biologically verified cocaine use
Cocaine use will be determined using quantitative and qualitative screens at least every 72 hours for 8 weeks.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Craig Rush, University of Kentucky
- Investigators
- Craig R. Rush, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444208
- Sponsor's protocol ID
- RCT (01)
- Other IDs
- R34DA038869
- Acronym
- RCT(01)
- Status last verified
- Jun 2018
- First submitted
- 11 May 2015
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial (01): A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use
- ClinicalTrials.gov ID
- NCT02444208
- Acronym / sponsor ID
- RCT(01) / RCT (01)
- Conditions
- Cocaine Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cocaine Inhibitory Control Training | Experimental | Behavioral: Active Inhibitory Control TrainingThis group will receive active inhibitory control training. |
| Neutral Inhibitory Control Training | Placebo comparator | Behavioral: Neutral Inhibitory Control TrainingThis group will receive neutral inhibitory control training. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Inhibitory Control TrainingSubjects will learn to inhibit responding in the presence of cocaine cues. | Behavioural | Cocaine Inhibitory Control Training |
| Neutral Inhibitory Control TrainingSubjects will learn to inhibit responding in the presence of neutral cues. | Behavioural | Neutral Inhibitory Control Training |
Primary outcome
Stop-Signal Task
Time frame: 8 weeks after study entry
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.
6 secondary outcomes
Retention
Time frame: 8, 9 and 10 weeks after study entry
Recruitment
Time frame: Three years
Treatment acceptability
Time frame: 8, 9 and 10 weeks after study
Protocol Adherence
Time frame: Three years
Self-Reported Cocaine Use
Time frame: 7 days
Biologically verified cocaine use
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig R. Rush, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cocaine Use Disorder, run by University of Kentucky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop-Signal Task (time frame: 8 weeks after study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.