Attention Training for Opioid-maintained Cocaine Users

Addiction Clinical Trial

Official title:

Attention Training for Opioid-maintained Cocaine Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870882
• Other study ID #: 1303011711
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive
• Cocaine
• Methadone
• Opiates

Intervention

Behavioral:
• Attentional retraining

• Control condition

Locations

Country	Name	City	State
United States	Department of Veterans Affairs Hospital	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	over the course of the 3 week training period
Primary	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.	over the course of the 3 week training period
Primary	Retention of participants in treatment		at the end of the 3 week training period
Primary	Mean duration of sessions with the PED		the duration of the 3 week training period
Secondary	self-reported craving for cocaine		assessed on a daily basis during the 3 week training period
Secondary	Self-reported cocaine use		during the 3 week training period
Secondary	Self-reported opioid use		during the 3 week training period
Secondary	self-reported craving for opiates		assessed on a daily basis during the 3 week training period
Secondary	Cocaine urine test results		during the 3 week training period
Secondary	opioid urine test results		during the 3 week training period