Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder

New York State Psychiatric Institute

Status and phase

Withdrawn

Phase 4

Conditions

Suicidal Ideation

Opioid-use Disorder

Treatments

Drug: Morphine Sulfate 30 mg

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04234516

IRB #7855

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No 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