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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately at day 7, 14, 21.
Awards & highlights
RAISE Trial 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.Check my eligibility
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.See study design
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.
RAISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried only one antidepressant without success, as per the MGH-ATRQ standards.
Select...
I have tried only one antidepressant without success, as per the MGH-ATRQ standards.
RAISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately at day 7, 14, 21.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately at day 7, 14, 21.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT0167516717%
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
RAISE 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
~3500
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable dose of thyroid medication for hypothyroidism for 3 months.You have had an allergic reaction to buprenorphine or naltrexone in the past.I am between 18 and 55 years old, speak English, and can understand and consent to the study.I failed the naloxone test or tested positive for opioids.I have tried only one antidepressant without success, as per the MGH-ATRQ standards.I do not have conditions or devices that could be affected by magnetic fields.You have been dependent on drugs or alcohol in the past 6 months, except for nicotine, or have abused drugs or alcohol in the past 2 months.I am currently taking opioid pain medication.You are currently taking opioids on a regular basis.I have stopped taking antidepressants for at least 21 days, or 5 weeks for fluoxetine.I am between 18 and 55 years old, speak English, and can understand and consent to the study.I have epilepsy or need medication to prevent seizures.I am currently undergoing treatments like vagus nerve stimulation or magnetic brain therapy.I am currently on medication for mental health or mood enhancement.I have tried only one antidepressant without success, as per the MGH-ATRQ standards.I am undergoing therapy specifically for depression, like CBT or IPT.I have stopped taking antidepressants for at least 21 days, or 5 weeks for fluoxetine.You are currently feeling very depressed and have thoughts of hurting yourself.You have a history of serious mental health conditions like depression, schizophrenia, bipolar disorder, or other psychotic disorders.You are currently experiencing severe symptoms of opioid withdrawal.
Research Study Groups:
This trial has the following groups:- Group 1: Buprenorphine Injection + Oral Placebo Pill
- Group 2: Naltrexone Oral Tablet + Intramuscular Saline Injection
- Group 3: Oral Placebo Pill + Intramuscular Saline Injection
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04276259 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this research endeavor involving?
"Affirmative. Data hosted on clinicaltrials.gov reveals that this medical experiment, which was initially submitted to the website on October 19th 2020, is still recruiting participants. Approximately 120 persons are needed from a single centre."
Answered by AI
What ailments is buprenorphine typically prescribed to address?
"Buprenorphine is a viable option for managing chronic weight, augmenting physical activity levels, and mitigating pain."
Answered by AI
Are there any open slots available for individuals who wish to participate in this research endeavor?
"Affirmative. The clinicaltrials.gov website reveals that as of April 20th 2022, this trial is still admitting participants which it began to seek on October 19th 2020. A total of 120 individuals are required for the study being held at one medical centre."
Answered by AI
Is enrollment open to individuals younger than 45 years old in this experiment?
"This medical study is looking for participants that have reached the age of consent, but are younger than 55 years old."
Answered by AI
Has the FDA sanctioned Buprenorphine for therapeutic use?
"Buprenorphine has been approved, so its safety rating is 3 on our scale of 1 to 3."
Answered by AI
What qualifications are necessary for potential participants in this experiment?
"To qualify for this clinical trial, participants must be suffering from depression and between 18-55 years of age. A total of 120 people will ultimately join the experiment."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Bellefield Tower
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried many Rx and am continuing to find help. I am feeling depressed - just diagnosed with macular degeneration.
PatientReceived no prior treatments
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