Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder
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|ClinicalTrials.gov Identifier: NCT04234516|
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : February 5, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
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
- 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.
- 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
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
|Contact: Mina M Rizk, MDemail@example.com|
|United States, New York|
|New York State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Mina Rizk, MD 929-305-5055 firstname.lastname@example.org|
|Principal Investigator:||Mina M Rizk, MD||Columbia University|