HealthyEarly Phase 1NCT01814410
Interactive Effects of IV Ethanol and IV Nicotine
A Early Phase 1 study testing intravenous ethanol 40mg% plus nicotine infusions and intravenous ethanol 100mg% plus nicotine infusions in people with Healthy, run by Yale University at 1 site in United States.
Trial summary
There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive performance and behavior in humans. The main objective of this study is to characterize the interactive effects of acute intravenous (IV) ethanol and nicotine administration on cognition and behavior in healthy smokers. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- intravenous ethanol 40mg% plus nicotine infusions and intravenous ethanol 100mg% plus nicotine infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2013to Jun 2014
- 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 and female;
- between the ages of 21 and 50 years;
- medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories
- history of smoking daily for the past 12 months, at least 5 cigarettes daily; not seeking treatment for nicotine dependence
- social drinkers no maximum level of alcohol consumption will be defined a priori but individuals who met current DSM -IV criteria for alcohol dependence (abuse will be allowed) will be excluded from the study.
Who cannot join
- history of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study;
- regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder;
- current abuse of any recreational or prescription drugs (except alcohol);
- alcohol naïve.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Haven VA Hospital
West Haven, Connecticut, 06516
About this study
Official title: A Laboratory Study on the Interactive Effects of IV Ethanol and IV Nicotine on Subjective Effects and Cognition
There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive performance and behavior in humans. The main objective of this study is to characterize the interactive effects of acute intravenous (IV) ethanol and nicotine administration on cognition and behavior in healthy smokers. The general hypothesis is that nicotine will attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative effects of ethanol.
- Conditions
- Healthy
- Being tested
- Intravenous ethanol placebo plus nicotine infusions, intravenous ethanol 40mg% plus nicotine infusions, intravenous ethanol 100mg% plus nicotine infusions
- Keywords
- Intravenous Ethanol, Intravenous Nicotine, Interactive effects, cognition, subjective effects, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ethanol placebo plus nicotine infusionsDrug
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
intravenous ethanol 40mg% plus nicotine infusionsDrug
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
intravenous ethanol 100mg% plus nicotine infusionsDrug
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
| Study group | Role | What they receive |
|---|---|---|
| intravenous ethanol placebo and nicotine infusions | Placebo comparator | Each subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations. Receives: Drug: Intravenous ethanol placebo plus nicotine infusions |
| intravenous ethanol 40% and nicotine infusions | Active comparator | Each subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations. Receives: Drug: intravenous ethanol 40mg% plus nicotine infusions |
| intravenous ethanol 100% and nicotine infusions | Active comparator | Each subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations. Receives: Drug: intravenous ethanol 100mg% plus nicotine infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biphasic Alcohol Effects Scale (BAES)
A 14-item scale with 7 items designed 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.
Measured: 2 minutes
Secondary outcomes (3)
Visual Analog Scales of Mood States
The following items will be assessed: high, depressed, anxious, drowsy, irritable, tired, sad, angry, nervous, nauseous, blurred vision, flushed, headache, lightheaded, dizzy, sweating, abdominal discomfort and tingling .
Measured: 1 minute
QSU-Brief
A measure of smoking urges reflecting not only intent and desire to smoke, and anticipation of pleasure from smoking, but also anticipation of relief from negative affect and nicotine withdrawal, and urgent and overwhelming desire to smoke.
Measured: 2 minutes
Digit Symbol Substitution Task
A test of psychomotor performance, which measures motor persistence, sustained attention, response speed and visuomotor coordination.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study start22 Feb 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- South Central VA Mental Illness Research, Education & Clinical Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ralevski, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814410
- Sponsor's protocol ID
- 1209010841
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2013
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Laboratory Study on the Interactive Effects of IV Ethanol and IV Nicotine on Subjective Effects and Cognition
- ClinicalTrials.gov ID
- NCT01814410
- Acronym / sponsor ID
- 1209010841
- Conditions
- Healthy
- Keywords
- Intravenous Ethanol, Intravenous Nicotine, Interactive effects, cognition, subjective effects, healthy subjects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- South Central VA Mental Illness Research, Education & Clinical Center
- Study start
- 22 Feb 2013 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Mar 2013 (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.
There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive performance and behavior in humans. The main objective of this study is to characterize the interactive effects of acute intravenous (IV) ethanol and nicotine administration on cognition and behavior in healthy smokers. The general hypothesis is that nicotine will attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative effects of ethanol.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intravenous ethanol placebo and nicotine infusions | Placebo comparator | Drug: Intravenous ethanol placebo plus nicotine infusionsEach subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations. |
| intravenous ethanol 40% and nicotine infusions | Active comparator | Drug: intravenous ethanol 40mg% plus nicotine infusionsEach subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations. |
| intravenous ethanol 100% and nicotine infusions | Active comparator | Drug: intravenous ethanol 100mg% plus nicotine infusionsEach subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female;
- between the ages of 21 and 50 years;
- medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories
- history of smoking daily for the past 12 months, at least 5 cigarettes daily; not seeking treatment for nicotine dependence
- social drinkers no maximum level of alcohol consumption will be defined a priori but individuals who met current DSM -IV criteria for alcohol dependence (abuse will be allowed) will be excluded from the study.
Key exclusion criteria (4 listed)
- history of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study;
- regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder;
- current abuse of any recreational or prescription drugs (except alcohol);
- alcohol naïve.
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 |
|---|---|---|
| Intravenous ethanol placebo plus nicotine infusionsnicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg | Drug | intravenous ethanol placebo and nicotine infusions |
| intravenous ethanol 40mg% plus nicotine infusionsnicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg | Drug | intravenous ethanol 40% and nicotine infusions |
| intravenous ethanol 100mg% plus nicotine infusionsnicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg | Drug | intravenous ethanol 100% and nicotine infusions |
Primary outcome
Biphasic Alcohol Effects Scale (BAES)
Time frame: 2 minutes
A 14-item scale with 7 items designed 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.
3 secondary outcomes
Visual Analog Scales of Mood States
Time frame: 1 minute
QSU-Brief
Time frame: 2 minutes
Digit Symbol Substitution Task
Time frame: 2 minutes
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 17 Jan 2018.
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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.
Elizabeth Ralevski, Ph.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 intravenous ethanol 40mg% plus nicotine infusions and intravenous ethanol 100mg% plus nicotine infusions in people with Healthy, 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 5 inclusion and 4 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 17 Jan 2018. 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?
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?
Biphasic Alcohol Effects Scale (BAES) (time frame: 2 minutes). 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 17 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.