Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia

NCT05778591 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB#23-000136
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Low social motivation is a significant symptom of schizophrenia and is a major cause of disability and suffering for many patients struggling with the illness. Social motivation refers to the drive to participate in or abstain from social activities. Many patients with schizophrenia evidence both decreased drive to seek positive social input (approach motivation) and heightened drive to avoid negative social input (avoidance motivation) compared to individuals without the illness. Despite the enormous burden of these deficits on patients, there are no medications that effectively treat impaired social motivation. Buprenorphine is an unusual drug that is used to treat opioid use disorder at higher doses and more recently, to treat depression and suicidality at lower doses. It is a unique opioid medication that has a compound action that gives it the potential to improve social motivation both by boosting approach motivation and by reducing avoidance motivation. The effects of low doses of buprenorphine have previously. been studied in healthy volunteers, showing that the drug enhances social motivation. These results in nonclinical volunteers suggest that buprenorphine may be a promising treatment for deficits in social motivation seen in some patients with schizophrenia. However, no previous studies have investigated the effects of buprenorphine on social motivation in this population. Here the effects of a low dose of buprenorphine (0.15mg) on social motivation in patients with schizophrenia (N=40) will be assessed. In this double-blind, cross-over, placebo-controlled study, participants will attend a 2-hour preparatory session and two 6-hour laboratory sessions, at which they will receive either placebo or buprenorphine. During expected peak drug effect they will complete validated tasks assessing social motivation. It is expected that buprenorphine will increase approach motivation and decrease avoidance motivation as measured by an attention bias task. The results of this study will lay the foundation for the clinical use of buprenorphine as the first medication to treat social deficits in schizophrenia.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Attention bias

  Number of gazes toward each stimulus type on the attention bias task.

  90 minutes after drug administration

Study Arms (2)

Placebo, buprenorphine

EXPERIMENTAL

One group will receive placebo first, then buprenorphine (0.15mg).

Drug: Placebo; Drug: Buprenorphine 0.15 MG [Belbuca]

Buprenorphine, placebo

EXPERIMENTAL

One group will receive buprenorphine (0.15mg) first, then placebo.

Drug: Placebo; Drug: Buprenorphine 0.15 MG [Belbuca]

Interventions

Placebo DRUG

Placebo.

Buprenorphine, placebo; Placebo, buprenorphine

Buprenorphine 0.15 MG [Belbuca] DRUG

Buprenorphine

Buprenorphine, placebo; Placebo, buprenorphine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-60
• able to understand spoken English sufficiently to comprehend testing procedures
• score below the mean of participants screened previously screened on the Lubben Social Network Scale
• DSM-5 diagnosis of schizophrenia
• clinical stability (i.e., no inpatient hospitalizations for six months prior to enrollment, no changes in medication in for 6 months prior to enrollment, no current positive symptoms greater than moderate)
• c) no history of IQ less than 70 or developmental disability, based on medical history d) no current use of opioid medication e) no clinically significant neurological disease (e.g., epilepsy), cardiovascular condition (e.g. cardiac arrhythmia), or respiratory condition (e.g., asthma) based on medical history
• no history of serious head injury (i.e., loss of consciousness longer than 1 hour, neuropsychological sequelae, cognitive rehabilitation treatment after head injury) based on medical history
• no substance or alcohol use disorder in the past six months, or history of opioid use disorder
• no sedatives, benzodiazepines within 24 hours of testing
• no positive urine toxicology screen or visible intoxication on the day of assessment
• no women who are pregnant or think that they might be pregnant, based on self-report and urine test

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Gerard De Vera

CONTACT

3107945577; gdevera@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 21, 2023
• Study Start: May 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)