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Trial · NCT04523792

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTreatment engagement - 1 month1 monthTreatment engagement as measured by percentage of participants who attend an outpatient clinic visit within 1 month of first injection.
SecondaryTreatment engagement - 3 and 6 months3 and 6 monthsTreatment engagement as measured by percentage of participants who continue to attend outpatient clinic visits with SUBLOCADE injections (buprenorphine treatment) at 3 and 6 months.
SecondaryNumber of repeat ED visits6 monthsNumber of repeat ED visits for any reason will be measured from electronic medical records and self-reported data.
OtherHealthcare resource utilization6 months
Healthcare resource utilization (measured by number of outpatient clinic and emergency department visits, and number of inpatient admissions) as compared to the concurrent and historical control groups.
OtherOpioid craving6 monthsOpioid craving in subjects as measured by Craving Visual Analog Scale (VAS), a 3-item scale in which individuals rate their cravings for opioids on a scale from 0 (NOT AT ALL) to 10 (EXTREMELY).
OtherNumber of participants with a urine drug screen negative for illicit opioids.6 monthsIllicit opioid use as measured by urine drug screen (UDS) results.
OtherImpulse control6 monthsTime to decision in delay discounting task
OtherOpioid cravings6 monthsBrief opioid demand task
OtherNumber of non-fatal or fatal opioid-related overdoses6 monthsData on the number of opioid overdoses will be measured from electronic medical records and/or state death registries.
OtherTreatment effectiveness: Treatment Effectiveness Assessment (TEA)6 months
Treatment effectiveness as measured by Treatment Effectiveness Assessment (TEA), which measures on 4 domains (substance use, health, lifestyle, community involvement). Responses on each item range from 1 ("not better at all") to 10 ("very much better") with items summed for a total score of 4-40, and higher scores reflecting greater self-report of treatment effectiveness.
OtherMedication satisfaction: Medication Satisfaction Questionnaire (MSQ)6 months
Measured by the Medication Satisfaction Questionnaire (MSQ), a single item that asks participants to rate how satisfied they are with their current opioid dependence medication on a scale from 1 ("extremely dissatisfied") to 7 ("extremely satisfied"). Higher scores reflect greater satisfaction with the medication.
OtherEmployment, presentism and absenteeism6 months
Assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), which measures the effects of opioid use disorder on the ability to work and perform regular activities among participants. Items evaluate hours of work completed and hours of work missed in the past 7 days and ask participants to rate the impact on their work productivity and regular activities in the past 7 days on a scale of 0 ("problem had no effect on my work/regular activities") to 10 ("problem completely prevented me from working/regular activities"), with higher scores reflecting greater severity and worse outcomes on the measure.

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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