An interventional study of self-administered, e-health application in Opioid-use Disorder, IV Drug Usage and Overdose, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Prevention
Among 1,222 studies in Opioid-Related Disorders with a site in United States — 245 open to participants now, 315 under way, 19 of them phase 3. Opioid-Related Disorders · United States.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, this one is the 747th largest by enrollment of the 1,097 interventional ones that give a count, is one of 43 that started in 2017, is one of 569 with no phase, and was the 447th registered.
1,473 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →245 of the 1,222 studies in Opioid-Related Disorders with a site in United States are open now. Recruiting first, the newest first:
Washington State University · Sites in United States
Ages 18+
University of Massachusetts, Worcester · Sites in United States
Ages 18+ · Healthy volunteers
Baylor College of Medicine · Sites in United States
Ages 18–64
Yale University · Sites in United States
Ages 25–65 · Healthy volunteers
Adneuris Therapeutics, Inc. · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 209 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 73 (35%) stop at 75 or younger; 14 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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1,222 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 162 · Phase 2 245 · Phase 3 100 · Phase 4 79
First in 1988; this study’s year is marked. 43 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 63 across 1,167 interventional studies indexed under Opioid-Related Disorders.
Median enrollment 56 across the 1,097 interventional studies, 85 across the 122 observational. Of the 834 that completed or were terminated, 331 (40%) have results posted.
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132 of 1,222 have an industry lead sponsor. The 10 most frequent:
University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
University of Cincinnati has 6 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
128 of the studies in Opioid-Related Disorders with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05011266Phase 3New York State Psychiatric InstituteEfficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | 2027-01-01 |
| NCT05834478Phase 3Emory UniversityNon-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3 | 2027-02 |
| NCT05033028Phase 3NYU Langone HealthSmartphones for Opiate Addiction Recovery | 2027-06-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT05766631Phase 3Friends Research Institute, Inc.Treating Polysubstance Use Using a Novel Digital Technology | 2027-06-30 |
Add all 128 to your calendar (.ics) → With an account.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, from their registry updates:
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The purpose of this research study is to:
The pre-post study of AWAITS will: 1) assess the acceptability of AWAITS as measured by participant feedback about the intervention; 2) test the impact of AWAITS on knowledge about opioid overdose, as measured by the OOTAS; 3) assess the proportion of participants who accept a list of local MAT treatment providers; and 4) test the impact of AWAITS on interest in being tested for HCV/HIV.
The acceptability of AWAITS will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. The average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. Pre-/post-changes in the percent of correct knowledge assessment items (i.e., about overdose and MAT) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The proportion of participants accepting a list of local MAT treatment providers will be calculated.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants who meet criteria will receive the AWAITS self-administered, e-health application intervention.
Other: self-administered, e-health application
AWAITS is a self-administered, e-health application and includes short videos in which patients who are successfully engaged in MAT discuss what they wish they had known about MAT when they were actively using. The intervention is designed to maximize "scalability" - the administration would entail handing an electronic device (e.g., tablet, laptop, etc.) to an individual who would then self-administer the intervention.
3 sections of the OOTAS (signs of overdose, how to respond to an overdose, and MAT)
To test the impact of AWAITS on knowledge about opioid overdose
Time frame: Day 1
Feedback on AWAITS
To assess the acceptability of the intervention
Time frame: Day 1
Acceptance of list of MAT providers
Assess relative interest in MAT post-AWAITS
Time frame: Day 1
Ran from Nov 2017 to primary completion in Jun 2018, 7 months.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's 7 months is below that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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