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Opiate Suicide Study in Patients With Major Depression

NCT04116528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-22

Study results available
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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.

Conditions

Interventions

DRUG

Buprenorphine

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

DRUG

Placebo

Sublingual troches of placebo (1-4 per day)

Sponsors & Collaborators

Principal Investigators

  • Alan F. Schatzberg · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2025-04-28
Completion
2025-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04116528 on ClinicalTrials.gov