Adjunctive ketamine vs. buprenorphine in co-occurring major depressive disorder and opioid use disorder: a randomized, double-blind clinical trial assessing anxiety symptom severity and craving intensity
Assessed by RV007 · Professor of Health Services Research
Assessed on 5 Nov 2025
OverallReviewer's overall integrity assessment, derived from all research questions Some concerns
DOI 10.1186/s13063-025-08836-4 (opens in new tab)
Resource ripekg:research-integrity-assessment/RIPEABC7D27C0BF8128FA
5 Research Questions · 2 Evidence Items
Q1.1 — Does the study have an associated retraction?
Rationale: No concerns.
Q1.2 — Does the study have an associated expression of concern or other relevant post-publication notice?
Rationale: No concerns.
Q1.3 — Do other studies by the research team highlight causes for concern?
Rationale: No concerns.
Q2.2 — Are there concerns relating to the timing or absence of study registration?
Rationale: Registration documents says recruitment started on 20th Feb 2022 (i.e., prospective registration). But no dates in actual trial report.
Supporting Evidence (2)
Clinical Trial RegistrationSource: Clinical trial registry (e.g. ClinicalTrials.gov, ISRCTN)
Registration ID: IRCT20211214053411N1
Registry: IRCT
Registry Link: https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20211214053411N1 (opens in new tab)
Registration Date: 10 Feb 2022
Prospective:Whether the trial was registered before participant recruitment began No
Assessment Rationale:How INSPECT-AI determined the prospective registration status by comparing dates LLM-extracted recruitment start date (normalized_date) is missing or empty.
Study Design EvidenceDates and timelines extracted by INSPECT-AI from the publication text
Recruitment Start: N/A
Recruitment Start Rationale:INSPECT-AI's reasoning for how it identified the recruitment start date No recruitment start date found after a full search of the document.
Recruitment End: N/A
Recruitment End Rationale:INSPECT-AI's reasoning for how it identified the recruitment end date No recruitment finish date found after a full search of the document.
Study End: N/A
Study End Rationale:INSPECT-AI's reasoning for how it identified the study end date No study end date found after a full search of the document.
Overall — What is the overall integrity assessment of the study?
Rationale: I've said 'Some concerns' because of the date of actual recruitment start (and end) not being in the paper. My gut-feeling is that this work is ok.