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Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder

Primary Purpose

Opioid-use Disorder, Suicidal Ideation

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

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

Morphine Sulfate 30 mg

About this trial

This is an interventional basic science trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Buprenorphine

Morphine

Arm Description

Sublingual buprenorphine-naloxone films

Oral morphine sulphate tablets

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04234516

First Posted

January 16, 2020

Last Updated

June 14, 2021

Sponsor

New York State Psychiatric Institute

1. Study Identification

Unique Protocol Identification Number

NCT04234516

Brief Title

Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder

Official Title

Functional Brain Mechanisms Underlying the Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Withdrawn

Why Stopped

PI leaving the institute

Study Start Date

January 20, 2020 (Actual)

Primary Completion Date

June 10, 2021 (Actual)

Study Completion Date

June 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The current opioid epidemic is an urgent public health problem, contributing significantly to the climbing U.S. suicide rates over the past two decades. Although initially rewarding, chronic opioid use leads to tolerance and escalating negative affective states. This may promote suicidal ideation and may further impair decision-making functions leading to suicidal behavior. Buprenorphine, a treatment for opioid use disorder (OUD), has promise in reducing suicidal ideation. However, the neural mechanism of its anti-suicidal properties remains unknown. Blocking kappa opioid receptors is one mechanism of buprenorphine hypothesized to reverse the negative emotional sensitivity in OUD and thus may underlie its anti-suicidal effects. In this morphine-controlled study, we will examine the effect of buprenorphine on the functional activity of brain regions involved in negative emotional reactivity and investigate whether this effect is associated with its anti-suicidal properties. Buprenorphine has a different mechanism of action than currently available antidepressants and anti-suicidal medications. Understanding this mechanism can help refine its use in this context. Success will guide a future larger study to elucidate molecular mechanisms underlying anti-suicidal properties of buprenorphine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder, Suicidal Ideation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

Double blind, double dummy

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buprenorphine

Arm Type

Active Comparator

Arm Description

Sublingual buprenorphine-naloxone films

Arm Title

Morphine

Arm Type

Active Comparator

Arm Description

Oral morphine sulphate tablets

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

buprenorphine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Morphine Sulfate 30 mg

Other Intervention Name(s)

morphine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 weeks

Title

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

Description

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

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mina M Rizk, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder

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