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

NCT ID: NCT05778591

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2026-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo, buprenorphine

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo.

Buprenorphine 0.15 MG [Belbuca]

Intervention Type: DRUG

Buprenorphine

Buprenorphine, placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo.

Buprenorphine 0.15 MG [Belbuca]

Intervention Type: DRUG

Buprenorphine

Interventions

Placebo

Placebo.

Intervention Type: DRUG

Buprenorphine 0.15 MG [Belbuca]

Buprenorphine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ages 18-60

2. able to understand spoken English sufficiently to comprehend testing procedures

3. score below the mean of participants screened previously screened on the Lubben Social Network Scale

4. DSM-5 diagnosis of schizophrenia

5. 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

1. 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

2. no substance or alcohol use disorder in the past six months, or history of opioid use disorder

3. no sedatives, benzodiazepines within 24 hours of testing

4. no positive urine toxicology screen or visible intoxication on the day of assessment

5. no women who are pregnant or think that they might be pregnant, based on self-report and urine test

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Anya Bershad, MD, PhD

Resident Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCLA Semel Institute

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gerard De Vera

Role: CONTACT

gdevera@mednet.ucla.edu

3107945577

Facility Contacts

Gerard De Vera

Role: primary

310-794-5577

Other Identifiers

IRB#23-000136

Identifier Type: -

Identifier Source: org_study_id