Back to resultsAttention Training for Opioid-maintained Cocaine Users
Primary Purpose
Addiction, Cocaine, Methadone
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Attentional retraining
Control condition
Sponsored by
About this trial
This is an interventional treatment trial for Addiction focused on measuring Opioid-Related Disorders, Cocaine-Related Disorders, Substance-Related Disorders, Mental Disorders, Cocaine, Methadone, Therapeutic Uses
Eligibility Criteria
Inclusion Criteria:
- Current opioid dependence as evidenced by 1) documentation of prior treatment for opioid dependence or signs of withdrawal, 2) self-reported history of opioid dependence for 12 consecutive months and, 3) a positive urine toxicology screen for opiates.
- Diagnosis of opioid dependence and cocaine dependence as well as laboratory confirmation of recent cocaine use in the form of positive urine toxicology during the month prior to study entry.
- For those who recently participated in a research study involving medications other than methadone, at least 2 weeks of washout period before enrollment. Those already taking methadone would continue with their current course while participating in this study.
- A history of cocaine use, a minimum of 1/2 gram and more than once per week during the preceding 30 days.
- Must be seeking treatment for opioid and cocaine use.
- For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.
- The ability to speak, read, and write in English at an eight-grade literacy level.
Exclusion Criteria:
- Serious medical illnesses including hypertension, tachycardia, bradycardia, or other arrhythmias and major cardiovascular, cerebrovascular, renal, endocrine, or hepatic disorders;
- Serious psychiatric illness, history of psychosis, schizophrenia or bipolar type I disorder.
- Current major depression. Subjects with current depressive symptoms not meeting criteria will be included in the study, with the exception of those endorsing suicidal and homicidal thoughts, will be excluded even if full criteria for major depression are not met.
- Current diagnosis of alcohol or drug dependence other than opiates, cocaine, nicotine and cannabis.
- Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
- Liver function tests (ALT or AST) greater than 3 times normal.
- Self-reported color blindness or (non-corrected) defective vision
Sites / Locations
- Department of Veterans Affairs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Retraining
Control
Arm Description
Using the PED, participants repeatedly complete a version of attentional bias task that orients their attention away from drug-related cues.
Using the PED, participants repeatedly complete versions of the attentional bias task in which their attention is oriented toward and away from drug-related cues on an equal number of trials.
Outcomes
Primary Outcome Measures
Attentional bias for cocaine cues
The tendency to respond more rapidly to a dot probe when the probe replaces a cocaine-related word than when a dot probe replaces a matched, non-drug control word.
Attentional bias for opioid cues
The tendency to respond more rapidly to a dot probe when the probe replaces an opioid-related word than when a dot probe replaces a matched, non-drug control word.
Retention of participants in treatment
Mean duration of sessions with the PED
Secondary Outcome Measures
self-reported craving for cocaine
Self-reported cocaine use
Self-reported opioid use
self-reported craving for opiates
Cocaine urine test results
opioid urine test results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01870882
Brief Title
Attention Training for Opioid-maintained Cocaine Users
Official Title
Attention Training for Opioid-maintained Cocaine Users
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the feasibility and preliminary efficacy of attention training using a portable electronic device for opioid-dependent cocaine-users stabilized on methadone.
Detailed Description
The investigators propose to test the feasibility and preliminary efficacy of 5-times per week daily attentional retraining (AR) delivered via a portable electronic device (PED) in comparison with a control condition over the course of a 2-3 week training period. Participants in this study will be cocaine and opioid-dependent individuals stabilized on methadone. Both cocaine and opioids will be targeted in the AR procedure the investigators will test in this study. The retraining or control condition, along with a series of assessments, will be delivered on the PED as part of a daily (Monday through Friday) appointment at which time participants will also obtain their daily methadone dose. Assessments will cover substance use, craving and other issues. In addition to completing the retraining or control procedure, participants will also be engaged in standard versions of attentional bias tasks (i.e., without retraining) periodically in order to gauge an effect of study condition on attentional bias over time. Thus, the investigators will be able to track changes in attentional bias over time in a more detailed fashion than has been previously possible. Following the 3 week training period, there will be another 3 weeks of treatment in which patients will continue to receive methadone and complete limited assessments without any AR or control procedures with the PED.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Cocaine, Methadone, Opiates
Keywords
Opioid-Related Disorders, Cocaine-Related Disorders, Substance-Related Disorders, Mental Disorders, Cocaine, Methadone, Therapeutic Uses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retraining
Arm Type
Active Comparator
Arm Description
Using the PED, participants repeatedly complete a version of attentional bias task that orients their attention away from drug-related cues.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Using the PED, participants repeatedly complete versions of the attentional bias task in which their attention is oriented toward and away from drug-related cues on an equal number of trials.
Intervention Type
Behavioral
Intervention Name(s)
Attentional retraining
Other Intervention Name(s)
attentional training, attentional bias retraining
Intervention Type
Behavioral
Intervention Name(s)
Control condition
Primary Outcome Measure Information:
Title
Attentional bias for cocaine cues
Description
The tendency to respond more rapidly to a dot probe when the probe replaces a cocaine-related word than when a dot probe replaces a matched, non-drug control word.
Time Frame
over the course of the 3 week training period
Title
Attentional bias for opioid cues
Description
The tendency to respond more rapidly to a dot probe when the probe replaces an opioid-related word than when a dot probe replaces a matched, non-drug control word.
Time Frame
over the course of the 3 week training period
Title
Retention of participants in treatment
Time Frame
at the end of the 3 week training period
Title
Mean duration of sessions with the PED
Time Frame
the duration of the 3 week training period
Secondary Outcome Measure Information:
Title
self-reported craving for cocaine
Time Frame
assessed on a daily basis during the 3 week training period
Title
Self-reported cocaine use
Time Frame
during the 3 week training period
Title
Self-reported opioid use
Time Frame
during the 3 week training period
Title
self-reported craving for opiates
Time Frame
assessed on a daily basis during the 3 week training period
Title
Cocaine urine test results
Time Frame
during the 3 week training period
Title
opioid urine test results
Time Frame
during the 3 week training period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current opioid dependence as evidenced by 1) documentation of prior treatment for opioid dependence or signs of withdrawal, 2) self-reported history of opioid dependence for 12 consecutive months and, 3) a positive urine toxicology screen for opiates.
Diagnosis of opioid dependence and cocaine dependence as well as laboratory confirmation of recent cocaine use in the form of positive urine toxicology during the month prior to study entry.
For those who recently participated in a research study involving medications other than methadone, at least 2 weeks of washout period before enrollment. Those already taking methadone would continue with their current course while participating in this study.
A history of cocaine use, a minimum of 1/2 gram and more than once per week during the preceding 30 days.
Must be seeking treatment for opioid and cocaine use.
For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.
The ability to speak, read, and write in English at an eight-grade literacy level.
Exclusion Criteria:
Serious medical illnesses including hypertension, tachycardia, bradycardia, or other arrhythmias and major cardiovascular, cerebrovascular, renal, endocrine, or hepatic disorders;
Serious psychiatric illness, history of psychosis, schizophrenia or bipolar type I disorder.
Current major depression. Subjects with current depressive symptoms not meeting criteria will be included in the study, with the exception of those endorsing suicidal and homicidal thoughts, will be excluded even if full criteria for major depression are not met.
Current diagnosis of alcohol or drug dependence other than opiates, cocaine, nicotine and cannabis.
Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
Liver function tests (ALT or AST) greater than 3 times normal.
Self-reported color blindness or (non-corrected) defective vision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert F Leeman, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Veterans Affairs Hospital
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
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Attention Training for Opioid-maintained Cocaine Users
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