Cognitive Functioning in Opioid Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-21

Study Completion Date

2024-06-30

Brief Summary

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This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose and cognitive functioning. This study will also examine the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life, drug use). The training component of the study lasts 1 month, with follow up visits and 1-month and 3-months post training.

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Detailed Description

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This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose (i.e. overdose that does not result in death), cognitive functioning, and the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life). Participants (n=30) with a history of at least one prior opioid OD, who are enrolled in buprenorphine treatment, will be randomized to 20 sessions of an active (n=15) or sham (n=15) working memory training. Patients will complete measures of cognitive functioning during screening, post-training, and at 1-month and 3-month follow up. Participants will also complete the measures of decision making, psychosocial functioning and drug use at baseline, post-training, and follow up.

Conditions

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Opioid Use Cognitive Change Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Participants and research staff will be blinded to participant's training condition (active vs. sham)

Study Groups

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Active

Working memory training with task-difficulty increasing across sessions

Group Type EXPERIMENTAL

CogMed

Intervention Type OTHER

20 sessions of Cogmed working memory training

Sham

Working memory training with task-difficulty remaining constant across sessions.

Group Type ACTIVE_COMPARATOR

CogMed

Intervention Type OTHER

20 sessions of Cogmed working memory training

Interventions

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CogMed

20 sessions of Cogmed working memory training

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Meets DSM-5 criteria for moderate-severe Opioid Use Disorder (OUD) in the past 6 months
* Enrolled in a suboxone (buprenorphine/naloxone) program; willing to provide consent for research team to contact treatment provider
* History of at least 1 prior opioid overdose
* Recent history of illicit opioid use
* In good physical health
* Access to a smartphone, tablet, or computer

Exclusion Criteria

* Evidence of a co-occurring, untreated psychiatric condition that would make participation risky or difficulty
* Lack of access to a home computer, smartphone, or tablet
* Unable to speak, read and/or communicate in English

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No