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Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04234516
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mina.Rizk, Columbia University

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Suicidal Ideation Drug: Buprenorphine/Naloxone 8/2 milligram (mg) Sublingual Film Drug: Morphine Sulfate 30 mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double blind, double dummy
Primary Purpose: Basic Science
Official Title: Functional Brain Mechanisms Underlying the Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : January 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Active Comparator: Buprenorphine
Sublingual buprenorphine-naloxone films
Drug: Buprenorphine/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.
Other Name: buprenorphine

Active Comparator: Morphine
Oral morphine sulphate tablets
Drug: Morphine Sulfate 30 mg
oral morphine sulphate 30 mg immediate release tablets q.i.d. + two sublingual Listerine strips at 8 pm
Other Name: morphine




Primary Outcome Measures :
  1. Changes in Beck Scale for Suicidal Ideation (SSI) scores from baseline to Week 2 post-treatment [ Time Frame: 2 weeks ]
    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. 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 [ Time Frame: 2 weeks ]
    fMRI negative picture task administered at baseline and week 2 post-treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234516


Contacts
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Contact: Mina M Rizk, MD 64767747518 mina.rizk@nypsi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Mina Rizk, MD    929-305-5055    minamaher85@gmail.com   
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Mina M Rizk, MD Columbia University

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Responsible Party: Mina.Rizk, Paul Janssen Postdoctoral Fellow, Columbia University
ClinicalTrials.gov Identifier: NCT04234516    
Other Study ID Numbers: IRB #7855
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Suicidal Ideation
Chemically-Induced Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Behavioral Symptoms
Morphine
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists