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A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders

Primary Purpose

Opioid Use Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Working Memory Task
Visual Search Task
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 or older
  • Currently receiving opioid use disorder treatment at McLean Hospital
  • Primary diagnosis of opioid use disorder
  • Currently prescribed medication treatment (agonist/partial agonist or antagonist) for opioid use disorder (*Note: does not apply to Stage 1A participants).
  • Own a smartphone with a touchscreen and a current data plan

Exclusion Criteria:

  • Acute suicidal ideation
  • Acute psychosis
  • Diagnosis of a neurological disorder
  • History of stroke
  • Diagnosis of a brain disease affecting cognitive function (e.g., tumor)
  • Score of less than 26 on the Montreal Cognitive Assessment (MoCA)

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Working Memory App (Active Intervention)

Visual Search App (Control Condition)

Arm Description

A visual-spatial app-based working memory intervention.

An app-based visual search task to be used as a control condition.

Outcomes

Primary Outcome Measures

Modified Craving Scale
A single-item craving measure adapted from the 3-Item Craving Scale (Weiss et al., 2003).
Dot Matrix Working Memory Task
A computerized version of a visual-spatial working memory task.

Secondary Outcome Measures

Full Information

First Posted
October 1, 2021
Last Updated
May 13, 2022
Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05086835
Brief Title
A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders
Official Title
A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Study ended prematurely due to PI departing institution for another position.
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Even when treated with methadone or buprenorphine maintenance, many people with opioid use disorder (OUD) continue to experience craving. Among both users of heroin and users of prescription opioids, mounting evidence shows that craving predicts return to use and undermines existing treatments for OUD, thus, the development of new interventions to reduce craving is a priority for addressing the opioid crisis (NIH HEAL Initiative Research Plan, 2019). Deficits in executive functioning, particularly working memory, are a central mechanism that undermines the ability to inhibit craving. Laboratory studies in non-clinical samples show that engaging in working memory tasks before or during a craving induction increases the ability to resist craving. This suggests that people with OUD may benefit from engaging in working memory tasks at the specific moment when craving occurs. Although previous research shows that working memory "training" does not improve clinical outcomes in OUD, these studies have not delivered training at the moment that craving actually occurs in daily life. Thus, engaging in working memory tasks at the moment that craving occurs could presumably help individuals with OUD to manage this persistent symptom, but this has not been tested. Further, studies using Ecological Momentary Assessment (EMA) methods show that people with OUD can accurately track moment-to-moment fluctuations in craving in their daily lives, suggesting that it may be feasible to deliver interventions for craving in the moment when craving is reported. This study will test the efficacy of embedding a mobile cognitive intervention into an EMA design in people with OUD. Using the NIH Stage Model of Intervention Development, Stage 1A of this project will optimize a working memory intervention based on iterative feedback from a sample of people with OUD (n = 20), in preparation for a Stage 1B trial using a randomized design. In this trial, participants with OUDs (n = 60) will complete a two-week EMA study in which they complete smartphone-based assessments of craving five times daily. When craving is reported, a mobile application containing the working memory intervention will activate. Half of the participants will complete the intervention, while half will complete a control task. At the conclusion of the trial, participants will be granted unrestricted access to the intervention during a feasibility phase. Outcomes include change in momentary craving, change in working memory performance, and feasibility and acceptability, including use of the intervention during follow-up. Substance use will also be assessed. This project supports the applicant's goal of leveraging cognitive mechanisms to conduct treatment development research for OUD. The applicant will receive training in the etiology and treatment of OUD, craving, mobile intervention development and human-centered design of interventions, and analysis of intensive longitudinal data. With its emphasis on modifying cognitive processes at the moment of craving, using mobile devices in patients' daily lives, this project has the potential to reveal new pathways for addressing a significant predictor of relapse in OUD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Working Memory App (Active Intervention)
Arm Type
Experimental
Arm Description
A visual-spatial app-based working memory intervention.
Arm Title
Visual Search App (Control Condition)
Arm Type
Active Comparator
Arm Description
An app-based visual search task to be used as a control condition.
Intervention Type
Other
Intervention Name(s)
Working Memory Task
Intervention Description
A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study.
Intervention Type
Other
Intervention Name(s)
Visual Search Task
Intervention Description
A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study.
Primary Outcome Measure Information:
Title
Modified Craving Scale
Description
A single-item craving measure adapted from the 3-Item Craving Scale (Weiss et al., 2003).
Time Frame
Change from pre-task to immediately post-task
Title
Dot Matrix Working Memory Task
Description
A computerized version of a visual-spatial working memory task.
Time Frame
Change from baseline to post-trial (at 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Currently receiving opioid use disorder treatment at McLean Hospital Primary diagnosis of opioid use disorder Currently prescribed medication treatment (agonist/partial agonist or antagonist) for opioid use disorder (*Note: does not apply to Stage 1A participants). Own a smartphone with a touchscreen and a current data plan Exclusion Criteria: Acute suicidal ideation Acute psychosis Diagnosis of a neurological disorder History of stroke Diagnosis of a brain disease affecting cognitive function (e.g., tumor) Score of less than 26 on the Montreal Cognitive Assessment (MoCA)
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders

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