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

NCT05086835 | Terminated Results

• 2 other identifiers: 2020P0041121K23DA051406-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• Modified Craving Scale

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

  Change from pre-task to immediately post-task

• Dot Matrix Working Memory Task

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

  Change from baseline to post-trial (at 2 weeks)

Study Arms (2)

Working Memory App (Active Intervention)

EXPERIMENTAL

A visual-spatial app-based working memory intervention.

Other: Working Memory Task

Visual Search App (Control Condition)

ACTIVE COMPARATOR

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

Other: Visual Search Task

Interventions

Working Memory Task OTHER

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

Working Memory App (Active Intervention)

Visual Search Task OTHER

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

Visual Search App (Control Condition)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and 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.

Results Point of Contact

• Title: Dr. Roger Weiss
• Organization: McLean Hospital

rweiss@mclean.harvard.edu

617-855-2242

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Psychology

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 21, 2021
• Study Start: October 14, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 10, 2022
• Results First Posted: June 10, 2022

Record last verified: 2022-05

Locations

US (1)