CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 enrolled
Drug / intervention
Buprenorphine +1 moredrug
Likely dose
Buprenorphine 0.8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04116528
NCT04116528Phase 3Completed
CompareCT.gov

Opiate Suicide Study in Patients With Major Depression

Stanford University·interventional·Posted Oct 4, 2019·Updated May 22, 2026

In Brief

A Phase 3 clinical trial evaluating Buprenorphine and Placebo for Major Depressive Disorder. Completed, enrolled 50 participants across 1 site.

Detailed Summary

To explore whether intravenous ketamine followed by buprenorphine produces more rapid and sustained anti-suicidal effects than ketamine followed by placebo, investigators will conduct a single study that will take approximately 2.5 years to complete. 60 subjects (60 infusions) or approximately 24 infusions per year.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 4, 2019
Enrollment StartAug 1, 2020
Primary CompletionApr 28, 2025
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 6.7 years ago

Interventions

Buprenorphinedrug

Sublingual troches of buprenorphine at doses from 0.2 to 0.8 mg per day (1-4 per day)

Placebodrug

Sublingual troches of placebo (1-4 per day)