Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers
ConditionHealthy Controls
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Commonwealth University
About this trial
The goal of this study is to do follow-up safety testing and how well people are able tolerate an experimental (not FDA approved) medication . This study is seeking non-illicit drug using adults to test the medication. Results of this study will help us to develop future studies to test the medication with people who use substances.
Eligibility criteria
Qualifiers
Demographics: Male or female, between 18 and 65 years of age.
High Impulsivity: Must demonstrate high impulsivity during the screening period, defined as an Immediate Memory Task (IMT) Commission Error by Correct Deletions (CE/CD) ratio > 0.25.
Informed Consent: Able to understand study procedures, follow instructions, and provide written informed consent in the English language.
Health Status: Be in generally good health based on medical history, physical exam, clinical laboratory values, vital signs, and ECG done during the screening period, as deemed by the Principal Investigator (PI) or designee.
Disqualifiers
Psychosis and bipolar disorder: Any lifetime history of psychosis or bipolar disorder.
Current Psychiatric Disorder: Current or recent (within the last year) DSM-5 diagnosis of any other psychiatric disorder that would make study participation unsafe, including but not limited to depressive disorders, trauma- or stress related disorders, and anxiety disorders that in the opinion of the investigator would make study participation unsafe.
Substance Use Disorder: Current DSM-5 diagnosis (any severity) of an alcohol or drug use disorder, or use of illicit/non-prescribed substances within the last 12 months.
Suicidality: Current or recent suicidal or homicidal ideation (C-SSRS "yes" answers on any questions) or a history of suicide attempt within the past 12 months.
Trial design
Treatments tested in this trial
- Placebo pills for 14-day intervention
- VVZ-2471 for 14-day intervention
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Virginia Commonwealth University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov