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Completed

NCT Number: NCT01870882

Attention Training for Opioid-maintained Cocaine Users

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.

Completed

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Veterans Affairs Hospital

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Attentional retraining

Behavioral

Other names: attentional training, attentional bias retraining

Control condition

Behavioral

Primary outcomes

  1. Attentional bias for cocaine cues

    Time frame: over the course of the 3 week training period

    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.

  2. Attentional bias for opioid cues

    Time frame: over the course of the 3 week training period

    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.

  3. Retention of participants in treatment

    Time frame: at the end of the 3 week training period

  4. Mean duration of sessions with the PED

    Time frame: the duration of the 3 week training period

Secondary outcomes

  1. self-reported craving for cocaine

    Time frame: assessed on a daily basis during the 3 week training period

  2. Self-reported cocaine use

    Time frame: during the 3 week training period

  3. Self-reported opioid use

    Time frame: during the 3 week training period

  4. self-reported craving for opiates

    Time frame: assessed on a daily basis during the 3 week training period

  5. Cocaine urine test results

    Time frame: during the 3 week training period

  6. opioid urine test results

    Time frame: during the 3 week training period

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 6, 2013
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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