Dose Escalation Study of Vinpocetine in Healthy Volunteers

Launched by STANFORD UNIVERSITY · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called vinpocetine to see if it is safe for healthy adults when taken in higher doses. The study is part of early research, known as Phase 1, which means it’s the first step in testing the drug on people. Researchers want to find out how the body handles vinpocetine and whether it has any side effects.

To participate in this trial, you need to be a healthy adult between the ages of 18 and 40, and you should be able to speak and understand English well. Women who can become pregnant must use effective contraception during the study. However, some people may not be eligible, such as those with serious health conditions like heart disease or cancer, or those who have a history of certain mental health issues. If you join the study, you’ll be closely monitored, and you can expect to receive detailed information about what taking vinpocetine involves. This research is important because it could help us learn more about the safety of this medication, particularly for conditions related to Fetal Alcohol Spectrum Disorders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy adults 18-40 years old.
• • 2. Proficient English.
• • 3. Use of appropriate contraception if woman of childbearing potential.
• Exclusion Criteria:
• • 1. Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression).
• • 2. Those who score \>18 overall on the BDI-II or \>0 for item #9 (suicidal thoughts) at screening.
• • 3. Use of centrally active medications.
• • 4. History of allergy to vinpocetine.
• • 5. IQ\<80.
• • 6. BMI≥30.
• • 7. Pregnancy or lactation.