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WithdrawnNCT04234516Updated Jun 18, 2021

Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder

A Phase 4 interventional study of Buprenorphine/Naloxone 8/2 milligram (mg) Sublingual Film and Morphine Sulfate 30 mg in Opioid-use Disorder and Suicidal Ideation, sponsored by New York State Psychiatric Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-06-18.

Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Basic science

Why this study was withdrawn
PI leaving the institute
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Opioid-use Disorder
  • Suicidal Ideation
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

Browse Opioid-Related Disorders studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Buprenorphine

    Sublingual buprenorphine-naloxone films

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

  • Active comparator
    Morphine

    Oral morphine sulphate tablets

    Drug: Morphine Sulfate 30 mg

Interventions

  • DrugBuprenorphine/Naloxone 8/2 milligram (mg) Sublingual Film

    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

  • DrugMorphine Sulfate 30 mg

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

    Also known as: morphine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

  2. 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

    Time frame: 2 weeks

07

Study locations

1 site
  • New York State Psychiatric Institute
    New York, New York 10032, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04234516
Lead sponsor
New York State Psychiatric Institute
Responsible party
Mina.Rizk (Paul Janssen Postdoctoral Fellow, Columbia University) — Principal investigator
First posted
Jan 21, 2020
Start date
Jan 20, 2020
Primary completion
Jun 10, 2021
Completion
Jun 10, 2021
Last update
Jun 18, 2021

Study contacts

Mina M Rizk, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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