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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a low dose of buprenorphine (0.15 mg) helps people with schizophrenia feel more willing to spend time with others and less likely to avoid them. It compares the drug with a placebo, which has no active medicine. Participants attend one 2-hour preparation visit and two 6-hour testing visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 60 years old.
  • Understand spoken English well enough to follow the testing steps.
  • Have a diagnosis of schizophrenia based on DSM-5, a guide used to diagnose mental health conditions.
  • Score below the average of people screened earlier on the Lubben Social Network Scale, a survey about social connections.
  • Have no hospital stays for treatment or medicine changes in the past 6 months, and no current symptoms such as hallucinations or delusions that are more than moderate.

Who can't join

  • A history of an IQ below 70 or a developmental disability.
  • Current use of opioid medicines.
  • A major brain or nerve disease, heart condition, or breathing condition, such as epilepsy, an irregular heartbeat, or asthma.
  • A serious past head injury that caused more than 1 hour of unconsciousness, lasting brain-related problems, or treatment to rebuild thinking skills.
  • An alcohol or drug use disorder in the past 6 months, or any history of opioid use disorder.
  • Use of sedatives or benzodiazepines, medicines that calm you or make you sleepy, within 24 hours before testing.
  • A positive urine drug test or visible signs of being drunk or high on the testing day.
  • Being pregnant or thinking you might be pregnant, based on your report and a urine test.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA