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Opioid
Low-Dose Buprenorphine for Schizophrenia
Phase 2
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-60
DSM-5 diagnosis of schizophrenia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes after drug administration
Summary
"This trial aims to investigate if a low dose of buprenorphine can improve social motivation in patients with schizophrenia. Social motivation is the drive to engage in social activities, and many patients with schizophrenia
Who is the study for?
This trial is for adults aged 18-60 with schizophrenia who have low social motivation, are clinically stable without hospitalizations or medication changes in the past six months, and do not currently use opioids. They should not have significant neurological, cardiovascular, respiratory conditions or a history of serious head injury. Substance abuse within the last six months is also disqualifying.
What is being tested?
The study tests if a low dose (0.15mg) of Buprenorphine can improve social motivation in people with schizophrenia compared to a placebo. It's a double-blind study where neither participants nor researchers know who receives the drug or placebo during two lab sessions after an initial preparatory session.
What are the potential side effects?
While specific side effects aren't listed here, Buprenorphine at higher doses can cause dizziness, drowsiness, constipation and may lead to addiction risk. Low doses as used in this trial might result in milder versions of these effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
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I have been diagnosed with schizophrenia.
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I have never had a serious head injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 minutes after drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes after drug administration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Attention bias
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo, buprenorphineExperimental Treatment2 Interventions
One group will receive placebo first, then buprenorphine (0.15mg).
Group II: Buprenorphine, placeboExperimental Treatment2 Interventions
One group will receive buprenorphine (0.15mg) first, then placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,249 Total Patients Enrolled
38 Trials studying Schizophrenia
4,827 Patients Enrolled for Schizophrenia