Clinical trial NCT01870882: Attention Training for Opioid-maintained Cocaine Users
Official title: Attention Training for Opioid-maintained Cocaine Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Addiction
Cocaine
Methadone
Opiates
Keywords: Opioid-Related Disorders
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Methadone
Therapeutic Uses
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Attentional bias for cocaine cues
timeFrame: over the course of the 3 week training period
measure: Attentional bias for opioid cues
timeFrame: over the course of the 3 week training period
measure: Retention of participants in treatment
timeFrame: at the end of the 3 week training period
measure: Mean duration of sessions with the PED
timeFrame: the duration of the 3 week training period
Secondary outcomes:
measure: self-reported craving for cocaine
timeFrame: assessed on a daily basis during the 3 week training period
measure: Self-reported cocaine use
timeFrame: during the 3 week training period
measure: Self-reported opioid use
timeFrame: during the 3 week training period
measure: self-reported craving for opiates
timeFrame: assessed on a daily basis during the 3 week training period
measure: Cocaine urine test results
timeFrame: during the 3 week training period
measure: opioid urine test results
timeFrame: during the 3 week training period
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Department of Veterans Affairs Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Robert F Leeman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: