Active Ethanol and Active IomazenilPhase 1NCT01590277

Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans

A Phase 1 study testing Active Ethanol and Active Iomazenil in people with Active Ethanol and Active Iomazenil and Active Ethanol and Placebo Iomazenil, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's effects on driving using a driving simulator. Read more about this study

Who is it for?: Ages 21 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Active Ethanol and Active Iomazenil, Active Ethanol and Placebo Iomazenil, Placebo Ethanol and Active Iomazenil
What is being tested?: Active Ethanol and Active Iomazenil
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 14 Dec 2012to 2 Nov 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Males
21-35 years old
Medically healthy

Who cannot join

Under the age of 21 or greater than the age 35
History of seizures

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516

Other trials in United States

About this study

Read the detailed description

Alcohol is abused commonly, but there is no antidote for alcohol intoxication the way naltrexone or naloxone is an antidote for opioids. A medication that has the potential to block alcohol actions in the Central Nervous System could act as a unique medication in the treatment of alcohol intoxication and alcoholism. This project is evaluating the benzodiazepine partial inverse agonist, iomazenil, as an agent that could reverse alcohol's effects on subjective intoxication, alcohol's effects on driving using a driving simulator and on measures of electrophysiology in the laboratory in healthy subjects.

Conditions: Active Ethanol and Active Iomazenil, Active Ethanol and Placebo Iomazenil, Placebo Ethanol and Active Iomazenil, Placebo Ethanol and Placebo Iomazenil, Alcohol Effect, Driving Under the Influence
Being tested: Active Ethanol, Active Iomazenil, Placebo
Medical subject headings: Driving Under the Influence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active EthanolDrug
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.
Active IomazenilDrug
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.
PlaceboDrug
Control: no alcohol, administered for a total of 90 minutes.
PlaceboDrug
Control: no iomazenil, administered for a total of 10 minutes

Study groups in NCT01590277
Study group	Role	What they receive
Active Ethanol and Active Iomazenil	Experimental	Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil Receives: Drug: Active Ethanol; Drug: Active Iomazenil
Active Ethanol and Placebo Iomazenil	Experimental	Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil Receives: Drug: Active Ethanol; Drug: Placebo
Placebo Ethanol and Active Iomazenil	Experimental	Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil Receives: Drug: Active Iomazenil; Drug: Placebo
Placebo Ethanol and Placebo Iomazenil	Placebo comparator	Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Biphasic Ethanol Effects Scale (BAES)
A 14-item scale with 7 items designated to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication. The BAES full scale would be 0 to 140. However, the scale itself is analyzed by breaking up the full 14 item scale into 2 parts - sedation and stimulation. Therefore, the total score for sedation ranges from 0 to 70, with higher scores indicating more sedation, and the total score for stimulation also ranges from 0 to 70, with higher scores indicating more stimulation.
Timepoints: Administered 160 mins (M160) and 10 mins (M10) prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached (0), and 15 (P15), 70 (P70), 90 (P90), and 150 (P150) minutes after the target ethanol/placebo dose has been reached.
Measured: Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 20122 Nov 2018

First posted2 May 2012 (estimated)
Study start14 Dec 2012
Primary completion2 Nov 2018
Study completion2 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Active Ethanol and Active IomazenilStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01590277
Sponsor's protocol ID: CLIN-026-11F
Status last verified: Sep 2024
First submitted: 30 Apr 2012
Last updated: 9 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
ClinicalTrials.gov ID: NCT01590277
Acronym / sponsor ID: CLIN-026-11F
Conditions: Active Ethanol and Active Iomazenil, Active Ethanol and Placebo Iomazenil, Placebo Ethanol and Active Iomazenil, Placebo Ethanol and Placebo Iomazenil, Alcohol Effect, Driving Under the Influence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 14 Dec 2012 (actual)
Primary completion: 2 Nov 2018 (actual)
Study completion: 2 Nov 2018 (actual)
First posted: 2 May 2012 (estimated)
Results: Posted 9 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Active Ethanol and Active Iomazenil	Experimental	Drug: Active Ethanol, Drug: Active IomazenilParticipants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Active Ethanol and Placebo Iomazenil	Experimental	Drug: Active Ethanol, Drug: PlaceboParticipants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Placebo Ethanol and Active Iomazenil	Experimental	Drug: Active Iomazenil, Drug: PlaceboParticipants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Placebo Ethanol and Placebo Iomazenil	Placebo comparator	Drug: PlaceboParticipants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil

Who may qualify

Ages: 21 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Males
21-35 years old
Medically healthy

Key exclusion criteria (2 listed)

Under the age of 21 or greater than the age 35
History of seizures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active EthanolTarget 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 Ethanol and Active Iomazenil, Active Ethanol and Placebo Iomazenil
Active IomazenilActive 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	Active Ethanol and Active Iomazenil, Placebo Ethanol and Active Iomazenil
PlaceboControl: no alcohol, administered for a total of 90 minutes.	Drug	Placebo Ethanol and Active Iomazenil, Placebo Ethanol and Placebo Iomazenil
PlaceboControl: no iomazenil, administered for a total of 10 minutes	Drug	Active Ethanol and Placebo Iomazenil, Placebo Ethanol and Placebo Iomazenil

Primary outcome

Biphasic Ethanol Effects Scale (BAES)
Time frame: Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.
A 14-item scale with 7 items designated to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication. The BAES full scale would be 0 to 140. However, the scale itself is analyzed by breaking up the full 14 item scale into 2 parts - sedation and stimulation. Therefore, the total score for sedation ranges from 0 to 70, with higher scores indicating more sedation, and the total score for stimulation also ranges from 0 to 70, with higher scores indicating more stimulation. Timepoints: Administered 160 mins (M160) and 10 mins (M10) prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached (0), and 15 (P15), 70 (P70), 90 (P90), and 150 (P150) minutes after the target ethanol/placebo dose has been reached.

Results and safety

Results posted to the registry on 9 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	33	26

Primary outcome: Biphasic Ethanol Effects Scale (BAES)

Time frame: Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.. Mean (Standard Deviation). Unit: score on a scale

Measure	Active Ethanol and Active Iomazenil n = 30	Active Ethanol and Placebo Iomazenil n = 31	Placebo Ethanol and Active Iomazenil n = 32	Placebo Ethanol and Placebo Iomazenil n = 32
Sedation Effects (Timepoint M160)	3.767 (6.826)	3.935 (7.771)	3.813 (7.368)	3.194 (5.431)
Sedation Effects (Timepoint M10)	4.767 (5.74)	4.484 (6.623)	3.438 (5.853)	3.968 (7.092)
Sedation Effects (Timepoint 0)	5.267 (5.271)	5.258 (6.153)	2.875 (5.74)	3.452 (6.35)
Sedation Effects (Timepoint P15)	7 (7.409)	5.677 (7.368)	6.75 (8.74)	3.387 (6.249)
Sedation Effects (Timepoint P70)	7.2 (11.075)	6.806 (9.393)	3.469 (6.17)	2.516 (5.092)
Sedation Effects (Timepoint P90)	4.9 (6.088)	5.677 (8.89)	2.875 (6.384)	1.452 (3.491)
Sedation Effects (Timepoint P150)	2.586 (4.594)	4.567 (7.257)	2.813 (5.688)	1.548 (3.897)
Stimulation Effects (Timepoint M160)	11.2 (11.152)	13 (13.844)	13.281 (12.606)	12.387 (11.292)

Adverse events

Time frame: Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Ethanol and Active Iomazenil	0 of 30 (0%)	3 of 30 (10%)	0 of 30
Active Ethanol and Placebo Iomazenil	0 of 31 (0%)	1 of 31 (3.2%)	0 of 31
Placebo Ethanol and Active Iomazenil	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32
Placebo Ethanol and Placebo Iomazenil	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deepak C D'Souza, MD MBBS principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biphasic Ethanol Effects Scale (BAES) (time frame: Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01590277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.