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Opioid Partial Agonist

Brain Stimulation for Depression (RAISE Trial)

Phase 4
Recruiting
Led By Marta Peciña, MD, PhD
Research Sponsored by Marta Peciña, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No more than one failed antidepressant trial of adequate dose and duration, as defined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ);
No more than one failed antidepressant trial of adequate dose and duration, as defined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ)
Must not have
Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids
Patients are receiving opioid analgesics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately at day 7, 14, 21.
Awards & highlights

Summary

This trial is investigating whether two different types of brain stimulation can help relieve symptoms of depression.

Who is the study for?
Adults aged 18-55 with major depression, who have tried at most one antidepressant without success, can join this trial. They must be fluent in English and off antidepressants for at least 21 days. People with a history of psychotic disorders, substance dependence (except nicotine), or those currently suicidal or on certain psychiatric medications cannot participate.
What is being tested?
The study tests if stimulating the brain's reward system using TMS and altering opioid signals with buprenorphine/naltrexone can improve depression symptoms. Participants will receive either real treatments or placebos to compare effects.
What are the potential side effects?
Possible side effects include discomfort from brain stimulation, reactions to medication like buprenorphine/naltrexone such as nausea, dizziness, or headaches. Placebo treatments may not cause direct side effects but won't provide active treatment benefits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried only one antidepressant without success, as per the MGH-ATRQ standards.
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I have tried only one antidepressant without success, as per the MGH-ATRQ standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I failed the naloxone test or tested positive for opioids.
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I am currently taking opioid pain medication.
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I have epilepsy or need medication to prevent seizures.
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I am currently undergoing treatments like vagus nerve stimulation or magnetic brain therapy.
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I am currently on medication for mental health or mood enhancement.
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I do not have conditions or devices that could be affected by magnetic fields.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately at day 7, 14, 21.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately at day 7, 14, 21. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BOLD Responses in the vmPFC-VS circuit
Opioid Modulation Effects on BOLD Responses in the vmPFC-VS circuit
TBS Effects of BOLD Response

Side effects data

From 2014 Phase 3 trial • 815 Patients • NCT01675167
17%
Nausea
8%
Constipation
7%
Vomiting
7%
Headache
5%
Dizziness
5%
Somnolence
1%
Drug withdrawal syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
OL Buprenorphine HCl Buccal Film
DB Buprenorphine HCl Buccal Film
DB Placebo Film

Trial Design

3Treatment groups
Experimental Treatment
Group I: Oral Placebo Pill + Intramuscular Saline InjectionExperimental Treatment3 Interventions
Inert pill and saline injection that have no inherent power to produce an effect. In the inert pill condition, participants will receive one IM arm injection of saline (1ML) and an oral placebo tablet.
Group II: Naltrexone Oral Tablet + Intramuscular Saline InjectionExperimental Treatment3 Interventions
Naltrexone is thought to strongly block μ-opioid receptors. Oral (pill) opioid antagonist which will be used to modulate reward learning signals to understand placebo effects in participants with depression. In the naltrexone condition, participants will receive one tablet of 50mg Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: \~1 hour; duration: \~24 hours) and a saline IM injection.
Group III: Buprenorphine Injection + Oral Placebo PillExperimental Treatment3 Interventions
Buprenorphine is a μ-opioid partial agonist and kappa-opioid antagonist that is used to treat moderate to severe pain and opioid dependence. The intramuscular administered opioid agonist which will be used to modulate reward learning signals to understand placebo effects in patients with depression. In the buprenorphine condition, participants will receive one IM injection of 0.3mg/1ML buprenorphine hydrochloride (Buprenex®. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc.; 2006) (onset of action: ≥15 minutes; peak effect: \~1 hour; duration: \~6 hours) and an oral placebo tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buprenorphine
2014
Completed Phase 4
~2600
Naltrexone
2005
Completed Phase 4
~2420
Oral Placebo
2017
Completed Phase 4
~3530
IM Placebo
2022
Completed Phase 1
~350

Find a Location

Who is running the clinical trial?

Marta Peciña, MD PhDLead Sponsor
2 Previous Clinical Trials
85 Total Patients Enrolled
1 Trials studying Depression
25 Patients Enrolled for Depression
Marta Peciña, MD, PhDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
1 Previous Clinical Trials
25 Total Patients Enrolled
1 Trials studying Depression
25 Patients Enrolled for Depression

Media Library

Buprenorphine (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04276259 — Phase 4
Depression Research Study Groups: Buprenorphine Injection + Oral Placebo Pill, Naltrexone Oral Tablet + Intramuscular Saline Injection, Oral Placebo Pill + Intramuscular Saline Injection
Depression Clinical Trial 2023: Buprenorphine Highlights & Side Effects. Trial Name: NCT04276259 — Phase 4
Buprenorphine (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04276259 — Phase 4
Depression Patient Testimony for trial: Trial Name: NCT04276259 — Phase 4
~33 spots leftby Mar 2026
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