Addiction
Conditions
Brief summary
The purpose of this research is to examine the potential for a new software-based behavioral support approach, for individuals with opioid use disorder, as an addition to usual care.
Detailed description
The purpose of this study is to examine the potential for a novel computer-based approach to mitigate the symptoms of opioid use disorder as part of a comprehensive treatment program. The study is designed as a single-arm field-test of cognitive training for individuals under supervised medical treatment for opioid use disorder. A custom and proprietary smartphone package (mHealth platform) comprises the intervention available to enrolled subjects for interaction over the study period. Commercial mobile devices serve as information presentation and data recording instruments. Additional outcome measures incorporate subject-reported data.
Interventions
DEVICEmHealth
Mobile platform
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
NXTech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years * Diagnosis of opioid use disorder * Experiencing symptoms multiple times per week * Familiar with smartphone usage
Exclusion criteria
\- None specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interaction Engagement, as Assessed by Interactions Completed | At 8 weeks | Interactions Completed (interactions completed, range 0 to unbound) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Usability Rating, as Assessed by Likert User Experience Scale | At 8 weeks | Subjective scoring of design and function usability, Likert User Experience Scale (score range 1-5, higher better) |
| Treatment Progress Measure, as Assessed by TEA Score | At 8 weeks | Patient-Centered instrument for evaluating progress, TEA Score (scale range 4 to 40, higher better), assessed weekly for 8 weeks with week 8 reported |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental MHealth group
MHealth: Mobile application | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex/Gender, Customized Declined to Report | 0 Participants |
| Sex/Gender, Customized Female | 14 Participants |
| Sex/Gender, Customized Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Interaction Engagement, as Assessed by Interactions Completed
Interactions Completed (interactions completed, range 0 to unbound)
Time frame: At 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental | Interaction Engagement, as Assessed by Interactions Completed | 7.3 interactions |
Secondary
Intervention Usability Rating, as Assessed by Likert User Experience Scale
Subjective scoring of design and function usability, Likert User Experience Scale (score range 1-5, higher better)
Time frame: At 8 weeks
Population: 18 of 21 participants did not complete survey at 8 week outcome measure time frame, resulting from technical error in survey delivery. 3 participants were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental | Intervention Usability Rating, as Assessed by Likert User Experience Scale | 4.7 units on a scale |
Secondary
Treatment Progress Measure, as Assessed by TEA Score
Patient-Centered instrument for evaluating progress, TEA Score (scale range 4 to 40, higher better), assessed weekly for 8 weeks with week 8 reported
Time frame: At 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental | Treatment Progress Measure, as Assessed by TEA Score | 19 score on a scale |