Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder

• Status: Withdrawn
• Trial end date: 2021-06-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Morphine; Naloxone

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