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Trial · NCT03809143

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryParticipant retentionRetention in dosing schedule at 48 weeks
To examine treatment retention at 48 weeks following initiation of monthly depot RBP-6000 buprenorphine injections in patients with opioid dependence transferred from a stable dose of sublingual buprenorphine.
SecondaryBUP-XR treatment retention and engagement in ongoing clinical care48 weeks
To examine BUP-XR treatment retention and engagement in ongoing clinical care at 48 weeks ortion of participants retained in treatment at 48 weeks following initiation of monthly depot buprenorphine injections and engaged in ongoing clinical care. Treatment retention is defined as remaining on active depot buprenorphine medication AND completing a clinical assessment at 48 weeks.
SecondaryChanges in opioid withdrawal48 weeksChange in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)
SecondaryChanges in client-reported opioid craving48 weeksChange in client-reported opioid craving assessed by opioid craving scale
SecondaryChanges in client-reported drug use48 weeksChange in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument
SecondaryBUP-XR dosing schedule adherence48 weeksTo evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation
SecondaryBUP-XR safety and tolerability48 weeksTo evaluate treatment safety and tolerability by monitoring adverse events, and events of clinical interest such as drug-drug interactions and pain management in clients treated with BUP-XR
SecondaryChanges in client-report pain and enjoyment48 weeksTo describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale
SecondaryDemographic factors associated with treatment retention48 weeksTo evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire
SecondaryClient treatment satisfaction score48 weeksClient-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)
SecondaryBUP-XR treatment costs48 weeksCosts to services delivering BUP-XR assessed by site-reported expenses and time and motion study

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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