Trial · NCT04995029
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 | Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38 | Weeks 20 to 38 | A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 20 to 38 inclusive. Opioid abstinence is defined as a negative urine drug screen (UDS) result and negative responses to the TimeLine Follow Back (TLFB) interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Primary | Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit | Week 2 | Treatment retention at Injection 2 was defined as the proportion of participants receiving Injection 2 at the Week 2 Visit among those in the Evaluable Population for Treatment Retention/Discontinuation. Participants who received Injection 2 at Week 2 (nominal) Visit and those who missed Injection 2 at Week 2 (nominal) Visit but received Injection 3 at the Week 6 Day 36 Visit were counted as "Yes" for treatment retention at Injection 2; otherwise, participants were counted as "No". |
| Secondary | Maintenance Phase: Percentage of Days Opioids Were Used Over Weeks 10 to 38 | Weeks 10 to 38 | Participants' percentage of days opioids were used out of days assessed over Weeks 10 to 38 (inclusive), based on the TLFB for the prior week. |
| Secondary | Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38 | Weeks 10 to 38 | A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 10 to 38 inclusive. Opioid abstinence is defined as a negative urine drug screen (UDS) result and negative responses to the TimeLine Follow Back (TLFB) interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. Opioid use will be assessed at 15 visits between Weeks 10 and 38. |
| Secondary | Maintenance Phase: Percentage of Visits With Opioid Abstinence Over Weeks 10 to 38 | Weeks 10 to 38 | Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Secondary | Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 30 to 38 | Week 30 to 38 | A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% for the last 5 visits planned for urine drug screen (UDS) and TimeLine Follow Back (TLFB) over Weeks 30 to 38 (inclusive). Opioid abstinence is defined as a negative UDS result and negative responses to the TLFB interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Secondary | Maintenance Phase: Percentage of Responders for Daily Opioid Use | Week 30 to 38 | A responder for daily opioid use is defined as a participant with 20% or less days of opioid use, based on the TimeLine Follow Backs (TLFBs) collected at the last 5 observed visits post randomization. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Secondary | Maintenance Phase: Percentage of Visits With Opioid Abstinence Overall | Week 2 to 38 | Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids at all assessments between Weeks 2 and 38. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Secondary | Maintenance Phase: Percentage of Days Opioids Were Used Overall | Week 2 to 38 | For each participant, the percentage of days opioids were used out of days assessed over Weeks 2 to 38 (inclusive), based on the TimeLine Follow Back (TLFB) for the prior week of each visit. |
| Secondary | Maintenance Phase: Percentage of Days Opioids Were Used Via the Injection Route | Weeks 10 to 38 | For participants who use opioids via the injection route for an average of 5 or more days per week in the last 4 weeks prior to Screening, the percentage of days opioids were used via the injection route out of days assessed based on the Timeline Follow Back (TLFB) interview for the prior week of each visit. |
| Secondary | Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit | Baseline to Week 38 | The average number of times opioids were used per week for a given visit based on the TimeLine Follow Back (TLFB) for the prior week collected at that visit. |
| Secondary | Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week | Baseline to Week 38 | The change in participants' number of times opioids were used per week from randomization baseline to each visit based on the 7 daily TimeLine Follow Back (TLFB) for the prior week collected at that visit. |
| Secondary | Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit | Baseline to Week 38 | Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids. |
| Secondary | Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit | Baseline to Week 38 | The average number of days opioids were used per week out of days assessed, based on the TimeLine Follow Back (TLFB) for the prior week of each visit. |
| Secondary | Maintenance Phase: Time From DB Randomization to Last Observed Study Visit (Treatment Retention) | Up to 288 days after randomization (accounting for out-of-window visits) | Treatment retention is defined as the number of days that participants remained in the treatment from randomization in the Maintenance Phase of the study until the date of the last observed study visit. The treatment retention since DB randomization is estimated using Kaplan-Meier method. The event is prematurely discontinuing the study prior to Week 38/EOT Visit. |
| Secondary | Maintenance Phase: Percentage of Participants Who Complete the Last Scheduled Injection | Week 34 | The proportion of randomized participants who completed the last scheduled injection of RBP-6000 at Week 34 were summarized using observed data. Missing data were not applicable for this endpoint. |
| Secondary | Induction Phase: Percentage of Participants Retained at 5 Weeks | 35 days | Percentage of participants retained at 5 weeks after the first dose of TM buprenorphine was estimated using the Kaplan-Meier product limit method. |
| Secondary | Induction Phase: Number of Participants With Adverse Events up to Injection 2 | Up to approximately 2 weeks | These endpoints encompassed all induction attempts and therefore utilized the first dose of transmucosal buprenorphine (TM BUP) for derivations. A treatment-emergent adverse event (TEAE) was defined as an AE having an onset date/time after administration of the first TM BUP dose and before the date/time of Injection 3. TEAEs up to RBP-6000 Injection 2 were TEAEs with a start date/time on or after the first dose of TM BUP and before the date/time of Injection 2. |
| Secondary | Induction Phase: Number of Participants With Adverse Events Between Injections 2 and 3 | Approximately 4 weeks | These endpoints encompassed all induction attempts and therefore utilized the first dose of transmucosal buprenorphine (TM BUP) for derivations. A treatment-emergent adverse event (TEAE) was defined as an AE having an onset date/time after administration of the first TM BUP dose and before the date/time of Injection 3. TEAEs between RBP-6000 Injections 2 and 3 were TEAEs with a start date/time on or after Injection 2 and before the date/time of Injection 3. |
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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