Attention Training for Opioid-maintained Cocaine Users

NCT ID: NCT01870882

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-06-30

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.

Conditions

Addiction; Cocaine; Methadone; Opiates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Retraining

Using the PED, participants repeatedly complete a version of attentional bias task that orients their attention away from drug-related cues.

Group Type: ACTIVE_COMPARATOR

Attentional retraining

Intervention Type: BEHAVIORAL

Control

Using the PED, participants repeatedly complete versions of the attentional bias task in which their attention is oriented toward and away from drug-related cues on an equal number of trials.

Group Type: SHAM_COMPARATOR

Control condition

Intervention Type: BEHAVIORAL

Interventions

Attentional retraining

Intervention Type: BEHAVIORAL

Control condition

Intervention Type: BEHAVIORAL

Other Intervention Names

attentional training; attentional bias retraining

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert F Leeman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Department of Veterans Affairs Hospital

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

1303011711

Identifier Type: -

Identifier Source: org_study_id