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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DA051270 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | mHealth group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth | Device | Mobile platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| Interaction Engagement, as Assessed by Interactions Completed | Interactions Completed (interactions completed, range 0 to unbound) | At 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At 8 weeks |
| Treatment Progress Measure, as Assessed by TEA Score |
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Inclusion Criteria:
Exclusion Criteria:
- None specified
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Vien, MD | PHNY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PHNY | Astoria | New York | 11106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | MHealth group MHealth: Mobile application |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | MHealth group MHealth: Mobile application |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Interaction Engagement, as Assessed by Interactions Completed | Interactions Completed (interactions completed, range 0 to unbound) | Posted | Mean | Full Range | interactions | At 8 weeks |
|
|
2 months, up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | MHealth group MHealth: Mobile application | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator for Study 31380 | NXTech | 7814721140 | external+studyinvestigator@nxtech.co |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2022 | Dec 15, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2022 | Dec 15, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
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Patient-Centered instrument for evaluating progress, TEA Score (scale range 4 to 40, higher better), assessed weekly for 8 weeks with week 8 reported |
| At 8 weeks |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 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) | 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. | Posted | Mean | Full Range | units on a scale | At 8 weeks |
|
|
|
| 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 | Posted | Median | Full Range | score on a scale | At 8 weeks |
|
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| 43 |
| 0 |
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| 0 |
| 43 |
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