Alcohol ConsumptionEarly Phase 1NCT00616746
Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans
A Early Phase 1 study testing Nicotine and Ethanol in people with Alcohol Consumption and Tobacco Use, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to characterize the interactive effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Tobacco Use
- What is being tested?
- Nicotine and Ethanol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female, 21 to 50 years old.
Who cannot join
- Alcohol or Nicotine Naive
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System, West Haven Campus
West Haven, Connecticut, 06516
About this study
The purpose of this study is to characterize the interactive effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol.
- Conditions
- Alcohol Consumption, Tobacco Use
- Being tested
- Nicotine, Ethanol
- Keywords
- Alcohol, nicotine
- Medical subject headings
- Alcohol Drinking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
1.0 microg/kg/min IV x 10 minutes
EthanolDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Three test days, within-subject design. Receives: Drug: Nicotine; Drug: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral and Cognitive Measures
Measured: Baseline and Test Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Early Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Responsible party
- Sponsor
- Investigators
- Deepak C D'Souza, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616746
- Sponsor's protocol ID
- 0607001614
- Status last verified
- Jul 2014
- First submitted
- 4 Feb 2008
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans
- ClinicalTrials.gov ID
- NCT00616746
- Acronym / sponsor ID
- 0607001614
- Conditions
- Alcohol Consumption, Tobacco Use
- Keywords
- Alcohol, nicotine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Study start
- Jan 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the interactive effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nicotine, Drug: EthanolThree test days, within-subject design. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or Female, 21 to 50 years old.
Key exclusion criteria (1 listed)
- Alcohol or Nicotine Naive
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 |
|---|---|---|
| Nicotine1.0 microg/kg/min IV x 10 minutes | Drug | 1 |
| EthanolIV | Drug | 1 |
Primary outcome
Behavioral and Cognitive Measures
Time frame: Baseline and Test Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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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, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nicotine and Ethanol in people with Alcohol Consumption and Tobacco Use, run by Yale University at 1 site in United States.
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 1 inclusion and 1 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 8 Jul 2014. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavioral and Cognitive Measures (time frame: Baseline and Test Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2014.