Opioid Use Disorder
Conditions
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.
Interventions
OTHERWorking Memory Task
A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study.
OTHERVisual Search Task
A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study.
Sponsors
National Institute on Drug Abuse (NIDA)
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Dot Matrix Working Memory Task | Change from baseline to post-trial (at 2 weeks) | A computerized version of a visual-spatial working memory task. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1A Intervention Development 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Stage 1A Intervention Development |
|---|---|
| Age, Continuous | 37.1 years STANDARD_DEVIATION 4.3 |
| Daily Questions Survey 3 times a day (e.g., once in the morning, at midday, and in the afternoon) | 7 Participants |
| Daily Questions Survey 5 times a day (e.g., about every 2-3 hours) | 1 Participants |
| Daily Questions Survey Once a day | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Modified Credibility and Expectancy Questionnaire Perceived benefit (expected improvement in craving) for control visual search task | 41.7 units on a scale STANDARD_DEVIATION 28.9 |
| Modified Credibility and Expectancy Questionnaire Perceived benefit (expected improvement in craving) for Working Memory Tetris Task | 65.5 units on a scale STANDARD_DEVIATION 28.2 |
| Modified Credibility and Expectancy Questionnaire Perceived helpfulness of control visual search task | 4.4 units on a scale STANDARD_DEVIATION 2.7 |
| Modified Credibility and Expectancy Questionnaire Perceived helpfulness of Tetris Working Memory Task | 6.5 units on a scale STANDARD_DEVIATION 2.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 10 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 10 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 10 |
Outcome results
Primary
Dot Matrix Working Memory Task
A computerized version of a visual-spatial working memory task.
Time frame: Change from baseline to post-trial (at 2 weeks)
Population: 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.
Primary
Modified Craving Scale
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
Population: 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.