Dose Escalation Study of Vinpocetine in Healthy Volunteers
ConditionFetal Alcohol Spectrum Disorders
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorStanford University
About this trial
The objective of this study is to determine whether vinpocetine is safe when taken at higher doses.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults 18-40 years old.
Proficient English.
Use of appropriate contraception if woman of childbearing potential.
Disqualifiers
Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression).
Those who score >18 overall on the BDI-II or >0 for item #9 (suicidal thoughts) at screening.
Use of centrally active medications.
History of allergy to vinpocetine.
Trial design
Design model
Single group
Treatments tested in this trial
Vinpocetine
DrugIncreasing doses of vinpocetine to assess tolerability.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: VinpocetineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events
Safety Outcome
Time frame
Approximately weekly treatments across ~4-6 visits per participant.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: