Attention Training for Opioid-maintained Cocaine Users



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:June 2013
End Date:June 2015

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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.

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.

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
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West Haven, Connecticut 06516
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