Trial · NCT04817410
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 | Day 14 | Number of participant enrolled with engagement in care of comprehensive addiction treatment |
| Primary | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 | Day 30 | Number of participant enrolled with engagement in care of comprehensive addiction treatment |
| Secondary | Number of Alcoholic Drinks Per Day | 7-days prior to enrollment to day of enrollment (baseline) | Baseline |
| Secondary | Number of Daily Drinks | 30-days | 30-days |
| Secondary | Daily Alcohol Craving Scale | up to 30 days | Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity. |
| Secondary | Guidelines Regimen Information Program (GRIP) Guide at Day 14 | Day 14 | Adherence to daily oral naltrexone measured using Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores mean better adherence. |
| Secondary | Guidelines Regimen Information Program (GRIP) Guide at Day 30 | Day 30 | Adherence to daily oral naltrexone measured using the Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores represent better adherence. |
| Secondary | Number of Pills in Bottle at Day 14 | Day 14 | Adherence to daily oral naltrexone measured using pill counts. |
| Secondary | Number of Pills in Bottle at Day 30 | Day 30 | Adherence to daily oral naltrexone measured using pill counts. |
| Secondary | Number of Heavy Drinking Days | up to 30 days | Number of heavy drinking days defined as 4 or more drinks for a woman or 5 or more drinks for a man on the same occasion in a 24 hour period. |
| Secondary | Health Services Utilization Survey | up to 30-days | Participants indicated the number of inpatient admissions, outpatient visits and emergency department visits over the preceding 7-days at baseline up to 30-days. Comparison of total reported admissions or visits were made using the Friedman test. No admissions or visits counted as a 0 for comparing across timepoints. If no response was provided at any of the three time points, the participant data was not used in the comparison. |
| Secondary | Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL) | Day 30 | Number of unhealthy days using the HRQoL. The HRQoL assesses core health days and activity limitations. Self-reported general health was collected on a 5-item scale ranging from: excellent, very good, good, fair, and poor. An unhealthy days score was obtained by summing the number of physically unhealthy and mentally unhealthy days. The minimum score is 0 and the maximum score is 30 unhealthy days, even if the number of unhealthy days totals more than 30. If no response was provided at the time points under comparison, the participant data was not used in the comparison. |
| Secondary | The Patient Rated Inventory of Side Effects (PRISE) Survey | Day 30 | Medication side effects of oral naltrexone measured using PRISE survey - is a patient self-report measure used to identify and evaluate the tolerability of side effect symptom. This scale is a 7-item assessment of the side effects in the following symptom areas; gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other. Each domain has multiple symptoms and for each domain the patient rates whether these symptoms are tolerable or distressing. Higher score represents more side-effects. What is reported below are the number of participants reporting side effects for each symptom. |
| Secondary | AUD Program Satisfaction Survey at Baseline | Baseline | Three elements of satisfaction were assessed: 1) convenience of screening, 2) difficulty of screening and 3) satisfaction with screening. Each question could be scored on scale of 0-6. For convenience of screening, lower numbers indicated more convenience. For difficulty of screening, lower numbers represent less difficulty. For satisfaction, higher numbers represent greater satisfaction. |
| Secondary | Number of Participants Who Transition to LA Injectable | Day 30 | Number of participants who transition from oral to long acting injectable naloxone. |
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
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GET https://conductscience.org/api/trials/v1/NCT04817410/registered