Attention Training for Opioid-maintained Cocaine Users

NCT01870882 | Completed Phase 4 DMC

• 1 other identifier: 1303011711
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Addiction; Cocaine; Methadone; Opiates

Keywords

Opioid-Related Disorders; Cocaine-Related Disorders; Substance-Related Disorders; Mental Disorders; Cocaine; Methadone; Therapeutic Uses

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Retention of participants in treatment

  at the end of the 3 week training period

• Mean duration of sessions with the PED

  the duration of the 3 week training period

Secondary Outcomes (6)

• self-reported craving for cocaine

  assessed on a daily basis during the 3 week training period

• Self-reported cocaine use

  during the 3 week training period

• Self-reported opioid use

  during the 3 week training period

• self-reported craving for opiates

  assessed on a daily basis during the 3 week training period

• Cocaine urine test results

  during the 3 week training period

Study Arms (2)

Retraining

ACTIVE COMPARATOR

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

Behavioral: Attentional retraining

Control

SHAM COMPARATOR

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.

Behavioral: Control condition

Interventions

Attentional retraining BEHAVIORAL

Also known as: attentional training, attentional bias retraining

Retraining

Control condition BEHAVIORAL

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Department of Veterans Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Behavior, Addictive; Opioid-Related Disorders; Cocaine-Related Disorders; Substance-Related Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Narcotic-Related Disorders; Chemically-Induced Disorders

Study Officials

• Robert F Leeman, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

US (1)