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Belbuca Buccal Product for Depression

Phase 3
Waitlist Available
Led By Jeffrey M Miller, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female.
Current major depressive episode.
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial will test if adding low-dose buprenorphine to standard depression treatment can reduce suicidal thoughts by studying brain activity.

Eligible Conditions
  • Depression
  • Suicidal Thoughts

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Anyone can participate regardless of gender.
You are currently experiencing a severe case of depression.
You have been having thoughts of harming yourself recently, and it's been rated as severe on a scale called the Columbia Suicide Severity Rating Scale (C-SSRS).


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Beck Scale for Suicidal Ideation (SSI) scores from pre- to Week 2 post-treatment.
Secondary outcome measures
Changes in functional magnetic resonance imaging (fMRI) blood oxygen- level dependent (BOLD) signal in the amygdala in response to negative vs. neutral pictures from pre- to Week 2 post-treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BuprenorphineExperimental Treatment1 Intervention
Buccal Films
Group II: PlaceboPlacebo Group1 Intervention
Buccal Films

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
474 Previous Clinical Trials
153,257 Total Patients Enrolled
81 Trials studying Depression
10,072 Patients Enrolled for Depression
Jeffrey M Miller, MDPrincipal InvestigatorNew York State Psychiatric Institute
2 Previous Clinical Trials
52 Total Patients Enrolled
2 Trials studying Depression
52 Patients Enrolled for Depression
Mina M Rizk, MDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are Belbuca Buccal Product's known side effects?

"Belbuca Buccal Product's safety is rated at a 3."

Answered by AI

How many subjects are involved in this experiment?

"The clinical trial is currently recruiting participants, with 30 patients needed from 1 location. Information on the study was first posted on 10/10/2022 and updated on 10/24/2022."

Answered by AI

Which type of patient is most likely to respond well to this treatment?

"Suicidal ideation is a primary criteria for being accepted into this trial. The age requirement is between 18 and 65 years old. There are only 30 spots available in total."

Answered by AI

Does this research require that participants be of a certain age?

"As specified in the eligibility requirements, adults aged 18 to 65 are able to enroll in this particular clinical trial."

Answered by AI

Are there any available positions for volunteers in this clinical trial?

"The listing for this clinical trial on clinicaltrials.gov says that the research team is currently looking for participants. The study was first announced on October 10th, 2020 and updated on October 24th, 2020."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
~0 spots leftby Apr 2025