Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder

NCT04234516 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB #7855
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to examine the effect of buprenorphine on suicidal ideation in individuals with opioid use disorder, and to investigate the functional brain activity related to its potential anti-suicidal effect.

Conditions

Opioid-use Disorder; Suicidal Ideation

Outcome Measures

Primary Outcomes (2)

• Changes in Beck Scale for Suicidal Ideation (SSI) scores from baseline to Week 2 post-treatment

  Clinician-based questionnaire measuring level of suicidal ideas over the last 7 days; 21 items scored 0 to 2; total score ranges from 0 to 38 (last 2 items not counted), higher scores mean more intense suicidal ideas.

  2 weeks

• Changes in functional magnetic resonance imaging (fMRI) blood oxygen-level dependent (BOLD) signal in the amygdala in response to negative vs. neutral pictures from baseline to Week 2 post-treatment

  fMRI negative picture task administered at baseline and week 2 post-treatment

  2 weeks

Study Arms (2)

Buprenorphine

ACTIVE COMPARATOR

Sublingual buprenorphine-naloxone films

Drug: Buprenorphine/Naloxone 8/2 milligram (mg) Sublingual Film

Morphine

ACTIVE COMPARATOR

Oral morphine sulphate tablets

Drug: Morphine Sulfate 30 mg

Interventions

Buprenorphine/Naloxone 8/2 milligram (mg) Sublingual Film DRUG

3 x 8 mg sublingual buprenorphine/naloxone films wrapped inside one Listerine strip at 8 pm daily + oral placebo pills q.i.d.

Also known as: buprenorphine

Buprenorphine

Morphine Sulfate 30 mg DRUG

oral morphine sulphate 30 mg immediate release tablets q.i.d. + two sublingual Listerine strips at 8 pm

Also known as: morphine

Morphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-55 years old
• Current opioid use disorder (mild, moderate or severe)
• Seeking treatment for opioid use disorder and willing to accept agonist-based therapy and be stabilized on buprenorphine when study is over
• Active suicidal ideation
• Participant must agree to voluntary admission to New York State Psychiatric Institute (NYSPI) inpatient research unit with confirmed bed availability
• Capacity to provide informed consent

You may not qualify if:

• Presence of chronic pain of sufficient severity as to require ongoing pain management with opioids
• Current active psychosis or mania
• Current moderate-severe alcohol, benzodiazepine, or other drug use likely to require a medical detoxification
• Unstable epilepsy or other neurological disorder
• A history of prior head trauma with evidence of cognitive impairment. Participants who endorse a history of prior head trauma will be administered Trail-making A and B test. Those who score 1.5 standard deviations below the mean on Trail- making A or B will be excluded from study participation
• Active significant medical illness that, in the opinion of the study physician, would make study participation hazardous to the participant or compromise study findings or would prevent the participant from completing the study (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease)
• Liver Function Tests (ALT, AST) greater than 5 times upper limit of normal
• On methadone-maintenance therapy
• Contraindication to any study treatment (e.g., Known allergy or sensitivity to buprenorphine)
• Pending legal action or other reasons that might prevent an individual from completing the study
• If female, currently pregnant or breastfeeding, or planning on conception
• Inadequate understanding of English
• 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 MRI scan
• Claustrophobia significant enough to interfere with MRI scanning
• Weight over 350 lbs or inability to fit into MRI scanner

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Suicidal Ideation

Interventions

Buprenorphine; Morphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Study Officials

• Mina M Rizk, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind, double dummy
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paul Janssen Postdoctoral Fellow

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: January 20, 2020
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)