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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05778591
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo.
  • Buprenorphine 0.15 MG [Belbuca] — DRUG
    Buprenorphine

Study Details

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.

Key Dates

Start date
May 17, 2024
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo, buprenorphine
    One group will receive placebo first, then buprenorphine (0.15mg).
  • Experimental: Buprenorphine, placebo
    One group will receive buprenorphine (0.15mg) first, then placebo.

Primary Outcome Measure

Attention bias [ Time Frame: 90 minutes after drug administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA Semel InstituteLos AngelesCalifornia90095
Gerard De Vera
310-794-5577

Find similar trials in Los Angeles, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
UCLA Semel Institute· Los Angeles, CA

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