Trial · NCT05062577
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants with >= 80% of urine samples negative for misuse of opioid drugs combined with self-reports negative for opioid use | Up to 12 weeks | Participants will undergo weekly assessments for misuse of opioid drugs through urine drug screening in combination with self-reports of opioid drug misuse. Percentage of participants with \>= 80% of urine samples negative for misuse of opioid drugs combined with self reports negative for opioid use will be reported. |
| Primary | Number of participants with Adverse Events (AEs) | Up to 16 weeks | Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study Investigational Product (IP) and other study treatments, whether or not considered related to the study IP and other study treatments. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study IP and other study treatments. This includes events related to the comparator and events related to the (study) procedures. An AE is considered "serious" if, the event: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important event. |
| Secondary | The cumulative distribution function (CDF) of the percentage of urine samples negative for misuse of opioid drugs combined with self-reports negative for opioid use | Up to 12 weeks | Participants will undergo weekly assessments for misuse of opioid drugs through urine drug screening in combination with self-reports of opioid drug misuse. The cumulative distribution function (CDF) of the percentage of urine samples negative for misuse of opioid drugs combined with self-reports negative for opioid use will be reported. |
| Secondary | Percentage of participants continuously abstinent from misuse of opioid drugs as assessed by urine samples and self-reports negative for opioid use | Up to 12 weeks | Participants will undergo weekly assessments for misuse of opioid drugs through urine drug screening in combination with self-reports of opioid drug misuse. Percentage of participants continuously abstinent from misuse of opioid drugs as assessed by urine samples and self-reports negative for opioid use will be reported. |
| Secondary | Total number of visits of abstinence from misuse of opioid drugs as assessed by urine samples and self-reports negative for opioid use | Up to 12 weeks | Participants will undergo weekly assessments for misuse of opioid drugs through urine drug screening in combination with self-reports of opioid drug misuse. Total number of visits of abstinence from misuse of opioid drugs will be reported. |
| Secondary | Number of participants with vital sign abnormalities and/or adverse events (AEs) | Up to 16 weeks | Number of participants with potentially clinically significant vital sign values. |
| Secondary | Number of participants with laboratory value abnormalities and/or adverse events (AEs) | Up to 16 weeks | Number of participants with potentially clinically significant laboratory values. |
| Secondary | Change from baseline in blood oxygen saturation (SpO2) | Baseline and up to 16 weeks | The blood oxygen saturation (SpO2) will be measured using a pulse oximeter placed on the participant's fingertip. Number of participants with low SpO2 levels will be reported. |
| Secondary | Number of participants with Routine 12-lead electrocardiogram (ECG) abnormalities and/or adverse events (AEs) | Up to 16 weeks | Number of participants with potentially clinically significant Routine 12-lead ECG values. |
| Secondary | Number of participants with suicidal ideation and/or suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 16 weeks | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported. |
| Secondary | Overall mortality (including opioid overdose mortality) | Up to 16 weeks | The number of participants for overall mortality and mortality due to opioid overdose will be summarized by treatment group. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05062577/registered