Status:
COMPLETED
Attention Training for Opioid-maintained Cocaine Users
Lead Sponsor:
Yale University
Conditions:
Addiction
Cocaine
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01870882
Start Date
June 1 2013
End Date
June 1 2015
Last Update
April 2 2020
Active Locations (1)
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1
Department of Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516