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

Sponsor
Mclean Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT05086835
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
10
1
2
4.5
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Working Memory Task
  • Other: Visual Search Task
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders
Actual Study Start Date :
Oct 14, 2021
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Working Memory App (Active Intervention)

A visual-spatial app-based working memory intervention.

Other: Working Memory Task
A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study.

Active Comparator: Visual Search App (Control Condition)

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

Other: Visual Search Task
A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study.

Outcome Measures

Primary Outcome Measures

  1. Modified Craving Scale [Change from pre-task to immediately post-task]

    A single-item craving measure adapted from the 3-Item Craving Scale (Weiss et al., 2003).

  2. Dot Matrix Working Memory Task [Change from baseline to post-trial (at 2 weeks)]

    A computerized version of a visual-spatial working memory task.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 McLean Hospital Belmont Massachusetts United States 02478

Sponsors and Collaborators

  • Mclean Hospital
  • National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Andrew D. Peckham, Instructor in Psychology, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT05086835
Other Study ID Numbers:
  • 2020P004112
  • 1K23DA051406-01A1
First Posted:
Oct 21, 2021
Last Update Posted:
Jun 10, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail By design, participants enrolled in the Stage 1A Intervention Development arm were enrolled prior to the primary clinical trial, and no data on primary study outcomes were collected during this initial treatment development phase.
Arm/Group Title Stage 1A Intervention Development
Arm/Group Description Adults receiving treatments for OUD. No randomization, and no intervention administered.
Period Title: Overall Study
STARTED 10
COMPLETED 10
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Stage 1A Intervention Development
Arm/Group Description Using the NIH Stage Model of Intervention Development, this study will consist of a non-randomized Stage 1A project designed to gather feedback from adults receiving treatments for OUD. This feedback will help our research team finalize a working memory intervention in preparation for a future Stage 1B trial using a randomized design.
Overall Participants 10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
37.1
(4.3)
Sex: Female, Male (Count of Participants)
Female
3
30%
Male
7
70%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
Not Hispanic or Latino
10
100%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
0
0%
White
8
80%
More than one race
1
10%
Unknown or Not Reported
1
10%
Region of Enrollment (participants) [Number]
United States
10
100%
Modified Credibility and Expectancy Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Perceived helpfulness of Tetris Working Memory Task
6.5
(2.4)
Perceived benefit (expected improvement in craving) for Working Memory Tetris Task
65.5
(28.2)
Perceived helpfulness of control visual search task
4.4
(2.7)
Perceived benefit (expected improvement in craving) for control visual search task
41.7
(28.9)
Daily Questions Survey (Count of Participants)
3 times a day (e.g., once in the morning, at midday, and in the afternoon)
7
70%
Once a day
2
20%
5 times a day (e.g., about every 2-3 hours)
1
10%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
This study was terminated prior to enrolling participants in either of the clinical trial study arms, so no outcome data were collected. Baseline data on the 10 participants who entered the Stage 1A study (designed to help inform the development of the clinical trial) are provided in the Baseline Characteristics section.
Arm/Group Title Working Memory App (Active Intervention) Visual Search App (Control Condition)
Arm/Group Description A visual-spatial app-based working memory intervention. Working Memory Task: A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study. An app-based visual search task to be used as a control condition. Visual Search Task: A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study.
Measure Participants 0 0
2. Primary Outcome
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)

Outcome Measure Data

Analysis Population Description
This study was terminated prior to enrolling participants in either of the clinical trial study arms, so no outcome data were collected. Baseline data on the 10 participants who entered the Stage 1A study (designed to help inform the development of the clinical trial) are provided in the Baseline Characteristics section.
Arm/Group Title Working Memory App (Active Intervention) Visual Search App (Control Condition)
Arm/Group Description A visual-spatial app-based working memory intervention. Working Memory Task: A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study. An app-based visual search task to be used as a control condition. Visual Search Task: A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study.
Measure Participants 0 0

Adverse Events

Time Frame 1 hour
Adverse Event Reporting Description This study was terminated prior to enrolling participants in either of the clinical trial study arms, so the number of participants at risk for Serious Adverse Events in the planned clinical trial is zero. All-cause mortality, and Other Adverse Events is 0 for both study arms. In addition, there were no Serious Adverse Events nor Other Adverse Events recorded in the participants enrolled in the Stage 1A phase (n = 10 participants total).
Arm/Group Title Working Memory App (Active Intervention) Visual Search App (Control Condition) Stage 1A Intervention Development
Arm/Group Description A visual-spatial app-based working memory intervention. Working Memory Task: A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study. An app-based visual search task to be used as a control condition. Visual Search Task: A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study. Using the NIH Stage Model of Intervention Development, this study will consist of a non-randomized Stage 1A project designed to gather feedback from adults receiving treatments for OUD. This feedback will help our research team finalize a working memory intervention in preparation for a future Stage 1B trial using a randomized design.
All Cause Mortality
Working Memory App (Active Intervention) Visual Search App (Control Condition) Stage 1A Intervention Development
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/10 (0%)
Serious Adverse Events
Working Memory App (Active Intervention) Visual Search App (Control Condition) Stage 1A Intervention Development
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/10 (0%)
Other (Not Including Serious) Adverse Events
Working Memory App (Active Intervention) Visual Search App (Control Condition) Stage 1A Intervention Development
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/10 (0%)

Limitations/Caveats

This study was terminated prior to enrolling participants in either of the clinical trial study arms, so no outcome data were collected. Baseline data on the 10 participants who entered the Stage 1A study (designed to help inform the development of the clinical trial) are provided in the Baseline Characteristics section.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Roger Weiss
Organization McLean Hospital
Phone 617-855-2242
Email rweiss@mclean.harvard.edu
Responsible Party:
Andrew D. Peckham, Instructor in Psychology, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT05086835
Other Study ID Numbers:
  • 2020P004112
  • 1K23DA051406-01A1
First Posted:
Oct 21, 2021
Last Update Posted:
Jun 10, 2022
Last Verified:
May 1, 2022