Trial · NCT05589181
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction | 7 days post-ED visit | The proportion of participants engaged in comprehensive addiction treatment at 7 days post-ED induction as verified by participant and the addiction treatment program. |
| Secondary | Percentage of days with opioid abstinence (Trial 1) | at day 7 | Participants' percentage of days with opioid abstinence (defined as negative urine drug screen (UDS)) at day 7 (Trial 1) |
| Secondary | Percentage of days with opioid use (Trial 1) | 7 days post-ED | Participants' percentage of days with opioid use at Time-Line Follow Back (TLFB) over 7 days post induction (inclusive) (Trial 1) |
| Secondary | Percentage of days with opioid use (Trial 2) | 30 days post-ED | Participants' percentage of days with opioid use at Time-Line Follow Back (TLFB) over 30 days post induction (inclusive) (Trial 2) |
| Secondary | Daily assessment of opioid use (Trial 1) | Days 1-7 after enrollment | Participants' daily assessment of opioid use out of days over a 7-day period (Trial 1) |
| Secondary | Change in number of times opioids used (Trial 1) | induction through 7 days | Change in participants' number of times opioids were per day used from induction through 7 days follow-up assessment (Trial 1) |
| Secondary | Change in number of times opioids used (Trial 2) | Baseline and follow-up assessment day 7 | Change in participants' number of times opioids were used from baseline to follow-up assessment day 7 (Trial 2) |
| Secondary | Change in number of times opioids used (Trial 2) | Baseline and follow-up assessment day 30 | Change in participants' number of times opioids were used from baseline to follow-up assessment day 30 (Trial 2) |
| Secondary | Proportion of participants with persistent nausea/vomiting during induction | at 240 minutes | Proportion of participants with persistent nausea/vomiting during the induction visit requiring treatment. |
| Secondary | Proportion of participants with a Pasero Opioid-induced Sedation Scale (POSS) score of 3 or higher | at 240 minutes | Proportion of participants with a POSS score of 3 or higher at the conclusion of the induction visit 4-hour observation period. Higher score indicates more severe sedation. S=sleep, easy to arouse 1. awake/alert 2. slight drowsy/easy aroused 3. Frequently drowsy, arousable, drifts off to sleep during conversation 4. Somnolent, minimal or no response to verbal and physical stimulation |
| Secondary | Proportion of participants with a Mini Mental Status Exam (MMSE) score indicating severe cognitive impairment | at 240 minutes | Proportion of participants with a Mini Mental Status Exam (MMSE) indicating severe cognitive impairment at the conclusion of the induction visit 4-hour observation period. The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language). Full scale ranges from 0-30, with higher scores indicating better function. |
| Secondary | Proportion of participants with precipitated or worsening withdrawal | up to 240 minutes | Proportion of participants with precipitated or worsening withdrawal requiring continued treatment with ancillary medications during the induction visit. |
| Secondary | Patient Satisfaction Survey | ED enrollment visit at 240 minutes | Patient Satisfaction Survey is a 4-item questionnaire, each item scores 1-5, with total score range of 4-20. Higher scores would indicate a higher level of satisfaction. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05589181/registered