Trial · NCT04225598
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | RCT Component: Patient engagement (yes/no) in formal addiction treatment at 7 days post randomization | 7 days post randomization | Engagement in formal addiction treatment will be defined as enrollment and receiving formal addiction treatment on the 7th day post randomization, confirmed by contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, opioid treatment programs (OTPs), intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD at 7 days to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics Anonymous (AA) or (Narcotics Anonymous) NA alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted. |
| Secondary | RCT Component: Engagement in MOUD (yes/no) at 7 days post randomization | 7 days post randomization | self-report verified with treatment provider(s) |
| Secondary | RCT Component: Patient engagement (yes/no) in formal addiction treatment at 30 days post randomization | 30 days post randomization | Engagement in formal addiction treatment will be defined as enrollment in formal addiction treatment on the 30th day post randomization, confirmed by direct contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, OTPs, intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD on the 30th day post randomization to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics or Narcotics Anonymous alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted. |
| Secondary | RCT Component: Patient Engagement in MOUD (yes/no) at 30 days post randomization | 30 days post randomization | self report verified with treatment provider(s) |
| Secondary | RCT Component: Self-reported days of illicit opioid use (past 7 days) at 7 days post randomization | 7 days post randomization | The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids. |
| Secondary | RCT Component: Self-reported days of illicit opioid use (past 7 days) at 30 days post randomization | 30 days post randomization | The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids. |
| Secondary | RCT Component: Craving scores at 7 days post randomization | 7 days post randomization | The investigators will use visual analogue scales (VAS) to assess craving, desire to use opioids and need to use opioids with a scale of 0-100. |
| Secondary | RCT Component: Healthcare services utilization (past 30 days) regarding ED visits and hospitalizations at 30 days post randomization | 30 days post randomization | A brief, structured interview regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment and self-help sources of support (e.g., NA). |
| Secondary | RCT Component: Patient satisfaction with BUP at 7 days post randomization | 7 days post randomization | The investigators will modify the patient satisfaction scale where overall experience is rated from 1 to 5 (1 is completely ineffective and 5 is completely effective) and treatment characteristics are rated 1 to 7 (1 is not important and 7 is extremely important) based on previous published data. |
| Secondary | RCT Component: Overdose Events at 30 days post randomization | 30 days post randomization | Assessment of past 30-day overdose events will be completed at 30 days post study enrollment. In addition, Site PIs will search local electronic medical records for fatal and non-fatal overdose events. |
| Secondary | Ancillary Component: Proportion of participants that experience a 5 or greater increase in COWS score within 4 hours of of XR-BUP administration | Within 4 hours of XR-BUP administration | Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal. |
| Secondary | Ancillary Component: Proportion of participants that transition to moderate withdrawal (COWS 13-24) within 4 hours of XR-BUP administration | Within 4 hours of XR-BUP administration | Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal. |
| Secondary | Ancillary Component: Proportion of participants that experience clinician determined precipitated withdrawal within 1 hour of XR-BUP administration | Within 1 hour post XR-BUP injection | Assessment of Proportion of participants that experience clinician determined precipitated withdrawal within 1 hour of XR-BUP administration. |
| Other | RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Engagement | 7 days post randomization | The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others. |
| Other | RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): QALYs | 7 days post randomization | The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others. |
| Other | RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Abstinent Years | 7 days post randomization | The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others. |
| Other | RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Engagement | 30 days post randomization | The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others. |
| Other | RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): QALYs | 30 days post randomization | The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others. |
| Other | RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Abstinent Years | 30 days post randomization | The final outcome measure for the cost-effectiveness analysis is the ICER (incremental cost-effectiveness ratio), which includes the relevant cost differential between the study arms in the numerator, and the difference in a chosen effectiveness measure in the denominator. 3 types of ICERs will be generated, each one with a different effectiveness measure (engagement in formal addiction treatment at 30 days; quality-adjusted life-years (QALYs) gained; and Abstinent Years). The reason being that different ICERs are more relevant to certain potential stakeholder groups than others. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
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