NCT01590277 - Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 14, 2012

Primary Completion Date

November 2, 2018

Study Completion Date

November 2, 2018

Conditions

Active Ethanol and Active IomazenilActive Ethanol and Placebo IomazenilPlacebo Ethanol and Active IomazenilPlacebo Ethanol and Placebo IomazenilAlcohol EffectDriving Under the InfluenceAlcohol Impairment

Interventions

DRUG

Active Ethanol

Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.

DRUG

Active Iomazenil

Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.

DRUG

Placebo

Control: no alcohol, administered for a total of 90 minutes.

DRUG

Placebo

Control: no iomazenil, administered for a total of 10 minutes

Trial Locations (1)

06516

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven

All Listed Sponsors

lead

VA Office of Research and Development

FED