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Trial · NCT05164549

Registered outcomes24

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

ListOutcomeTime frameDescription
PrimaryCount of days abstinent From illicit/non-medical opioids during weeks 2 to 24 (range: 0-161 days)24 weeksCombining self-report information from Time-Line Follow-Back interview adapted from the Treatment Outcomes Profile and incorporating data from 12 scheduled urine drug screens.
SecondaryClinical superiority of XR-Bup plus PSI versus Bup/Met plus PSI24 weeks
Number of days abstinent from cocaine Days 8 - 168 Number of days abstinent from Benzodiazepines Days 8 - 168 Longest time in days continuously abstinent from heroin Days 8 - 168 Longest time in days continuously abstinent from cocaine Days 8 - 168 Longest time in days continuously abstinent from Benzodiazepines Days 8 - 168
SecondaryCost-effectiveness of XR-BUP versus Bup and Met24 weeksBased on the incremental cost per quality-adjusted life year (QALY) gained.
SecondarySafety of XR-Bup24 weeksNumber of safety events from study enrolment to 24 weeks
SecondaryTime (days) enrolled in study treatment (retention) to week 2424 weeks
SecondaryOUD remission status (DSM5 OUD severity; SCID-5-RV)24 weeks
SecondaryClinician rating of severity, complexity and recovery strengths: ADAPT24 weeks
SecondaryClinician global impression of severity and improvement): CGI-S/I;24 weeks
SecondaryCount of days abstinent from cocaine and illicit/non-medical benzodiazepines24 weeks
During weeks 2 to 24 (range: 0-161 days); combining self-report information from Time-Line Follow-Back interview adapted from the Treatment Outcomes Profile and incorporating data from 12 scheduled urine drug screens
SecondaryFrequency of opioid (H) and cocaine (C) craving experience: CEQ-F(H) and CEQ-F(C)24 weeks
SecondaryCraving need and want strength for heroin and cocaine: VAS-N(H/C) and VAS-W(H/C)24 weeks
SecondaryDifficulties in Emotion Regulation (Short Form): DERS-SF24 weeks
SecondaryDepression symptoms: QIDS-SR24 weeks
SecondaryWork and social adjustment: WSAS24 weeks
SecondarySubjective recovery and improvement: SURE24 weeks
SecondaryPatient rating of OUD severity and improvement:24 weeksUtilising PRO-S/I;
SecondaryPatient rating of OUD severity and improvement:24 weeksCognitive impairment: MoCA
SecondaryAlcohol consumption: typical quantity and frequency: (ALC-QFM)24 weeks
SecondaryLonger Term OutcomesThrough study completion, up to 4 yearsAmong participants enrolled in longer term XR-BUP treatment: heroin, cocaine and illicit/non-medical benzodiazepine use in past 90 days (TLFB; UDS)
SecondaryLonger Term OutcomesThrough study completion, up to 4 yearsAmong participants enrolled in longer term XR-BUP treatment: OUD and CUD remission status (SCID-5-RV)

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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