NCT05778591 Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia
| NCT ID | NCT05778591 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Los Angeles |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-17 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-05-17 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 us
Frequently Asked Questions
Who can join the NCT05778591 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05778591 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05778591 currently recruiting?
Yes, NCT05778591 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of California, Los Angeles to inquire about joining.
Where is the NCT05778591 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05778591 clinical trial?
NCT05778591 is sponsored by University of California, Los Angeles. The trial plans to enroll 40 participants.
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