| Eligibility |
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the
duration of the study.
3. Male or female.
4. Aged 18-65 years.
5. Ability to take oral medication and be willing to adhere to the treatment regimen.
6. Current major depressive episode.
7. Hamilton Depression Rating Scale (HDRS) Score > 16.
8. Active suicidal ideation (Columbia Suicide Severity Rating Scale (C-SSRS) of 3 or
more).
9. Participants must have been on a medication regimen for depression that includes an
adequate dose of antidepressant for at least the past 4 weeks.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation
in this study:
1. Current active psychosis or mania.
2. Current or past alcohol use disorder or substance use disorder involving any
prescribed or any illicit drug (opioid, benzodiazepine, or other drug use) including
mild severity.
3. Family history of alcohol or substance use disorder in a first-degree relative.
4. Current or past history of prescription or non-prescription opioid use.
5. History of other risk factors for the development of opioid misuse and opioid use
disorder other than comorbid depression (e.g., homelessness, criminal record,
aggressive or violent behavior that resulted in injury to another person).
6. Current acute or chronic pain.
7. Neurological disorders (e.g., epilepsy, brain tumors or patients with increased
intracranial pressure due to other reasons).
8. A history of prior head trauma with evidence of cognitive impairment. Participants who
endorse a history of prior head trauma will be administered the Trail-making A and B
test. Those who score 1.5 standard deviations below the mean on the Trail-making A or
B will be excluded from study participation.
9. Active significant medical illness that would make study participation hazardous to
the participant or compromise study findings or would prevent the participant from
completing the study (e.g., oral mucositis, orthostatic hypotension, history of
hypotensive disorders, hypokalemia, hypomagnesemia, or clinically unstable cardiac
disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable
congestive heart failure, or active myocardial ischemia, history of Long QT syndrome
or immediate family member with this condition, moderate to severe hepatic impairment
or hepatitis, liver cirrhosis , severe chronic pulmonary diseases, significant
respiratory depression, acute or severe bronchial asthma, known or suspected
gastrointestinal obstruction, including paralytic ileus).
10. Participants taking medications that prolong the QT interval (e.g., Class IA
antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III
antiarrhythmic medications (e.g., sotalol, amiodarone, dofetilide)).
11. Participants taking medications with potentially clinically-significant drug
interactions with BELBUCA , including benzodiazepines, central nervous system (CNS)
depressants (e.g., alcohol, anxiolytics, general anaesthetics, hypnotics,
neuroleptics, phenothiazines, sedatives, tranquilizers), other opioid analgesics,
muscle relaxants, diuretics, anticholinergic drugs, non-nucleoside reverse
transcriptase inhibitors (e.g., efavirenz, nevirapine, etravirine, delavirdine),
protease inhibitors (e.g., atazanavir, ritonavir). Additionally, patients must
discontinue CYP3A4 strong inhibitors (e.g., clarithromycin, telithromycin, nefazodone,
itraconazole, ketoconazole) 2 weeks before initiation of the study.
12. Known allergy or sensitivity to buprenorphine.
13. If female, pregnancy, abortion or miscarriage in the previous two months, current
breastfeeding or plans to conceive during the course of study participation. Patients
who are not on contraceptives will be asked to at least use barrier methods during
sexual intercourse. All patients must commit to not attempting to become pregnant
during participation in the study.
14. Inability to read and speak English fluently.
15. Metal implants or paramagnetic objects contained within the body (including heart
pacemaker, shrapnel, or surgical prostheses) which may present a risk to the subject
or interfere with the MR scan, according to the guidelines set forth in the following
reference book commonly used by neuroradiologists: "Guide to MR procedures and
metallic objects", F. G. Shellock, Lippincott Williams and Wilkins NY 2001.
Additionally, transdermal patches will be removed during the MRI.
16. Claustrophobia significant enough to interfere with MRI scanning.
17. Weight over 350 lbs or inability to fit into MRI scanner.
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