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Trial Outcomes & Findings for A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders (NCT NCT05086835)

NCT ID: NCT05086835

Last Updated: 2022-06-10

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Change from pre-task to immediately post-task

Results posted on

2022-06-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Stage 1A Intervention Development
Adults receiving treatments for OUD. No randomization, and no intervention administered.
Overall Study
STARTED
10
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Stage 1A Intervention Development
n=10 Participants
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.
Age, Continuous
37.1 years
STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
8 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Region of Enrollment
United States
10 participants
n=5 Participants
Modified Credibility and Expectancy Questionnaire
Perceived helpfulness of Tetris Working Memory Task
6.5 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
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 • n=5 Participants
Modified Credibility and Expectancy Questionnaire
Perceived helpfulness of control visual search task
4.4 units on a scale
STANDARD_DEVIATION 2.7 • n=5 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 • n=5 Participants
Daily Questions Survey
3 times a day (e.g., once in the morning, at midday, and in the afternoon)
7 Participants
n=5 Participants
Daily Questions Survey
Once a day
2 Participants
n=5 Participants
Daily Questions Survey
5 times a day (e.g., about every 2-3 hours)
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

Working Memory App (Active Intervention)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Visual Search App (Control Condition)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Stage 1A Intervention Development

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Roger Weiss

McLean Hospital

Phone: 617-855-2242

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place