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Trial · NCT04817410

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14Day 14ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30Day 30ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Alcoholic Drinks Per Day7-days prior to enrollment to day of enrollment (baseline)# of drinks consumed per dayMEDIAN
SECONDARYNumber of Daily Drinks30-days30-days# of drinks consumed per dayMEDIAN
SECONDARYDaily Alcohol Craving Scaleup to 30 daysscore on a scaleMEDIAN
SECONDARYGuidelines Regimen Information Program (GRIP) Guide at Day 14Day 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.
units on a scaleMEDIAN
SECONDARYGuidelines Regimen Information Program (GRIP) Guide at Day 30Day 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.
units on a scaleMEDIAN
SECONDARYNumber of Pills in Bottle at Day 14Day 14Pill count at day 14. Note: Participants did not return to clinic so pill counts were not collected.
SECONDARYNumber of Pills in Bottle at Day 30Day 30Pill counts at day 30 Note: Participants did not return to clinic so pill counts were not collected.
SECONDARYNumber of Heavy Drinking Daysup to 30 daysdaysMEDIAN
SECONDARYHealth Services Utilization Surveyup to 30-days
Participants indicated the number of inpatient admissions, outpatient visits and emergency department visits over the preceding 7-days at baseline, 14-days and 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.
number of occurrencesMEDIAN
SECONDARYNumber of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL)Day 30
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.
unhealthy daysMEDIAN
SECONDARYThe Patient Rated Inventory of Side Effects (PRISE) SurveyDay 30participantsNUMBER
SECONDARYAUD Program Satisfaction Survey at BaselineBaseline
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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Who Transition to LA InjectableDay 30ParticipantsCOUNT_OF_PARTICIPANTS

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.

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