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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05778591
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Placebo; Drug: Buprenorphine 0.15 MG [Belbuca]	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Placebo, buprenorphine One group will receive placebo first, then buprenorphine (0.15mg).	Drug: Placebo; Placebo.; Drug: Buprenorphine 0.15 MG [Belbuca]; Buprenorphine
Experimental: Buprenorphine, placebo One group will receive buprenorphine (0.15mg) first, then placebo.	Drug: Placebo; Placebo.; Drug: Buprenorphine 0.15 MG [Belbuca]; Buprenorphine

Outcome Measures

Primary Outcome Measures

1. Attention bias [90 minutes after drug administration]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anya Bershad, MD, PhD, Resident Physician, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT05778591
• Other Study ID Numbers: IRB#23-000136
• First Posted: Mar 21, 2023
• Last Update Posted: Mar 21, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Schizophrenia; Buprenorphine

Study Results

No Results Posted as of Mar 21, 2023