Alcohol ReactivityPhase 2NCT01000987

Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders

A Phase 2 study testing varenicline in people with Alcohol Reactivity, run by Yale University 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

The purpose of this study is the examine the effect of varenicline on cognition to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Alcohol Reactivity
What is being tested?: varenicline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Nov 2016
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

21 years old or older
Able to read and write in English
Smokers and nonsmokers
Meet criteria for alcohol use disorders
Currently enrolled in NCT00580645

Who cannot join

Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
Significant hepatocellular injury
Positive test results at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
Women who are pregnant or nursing
Suicidal, homicidal, or evidence of severe mental illness
Prescription of any psychotropic drug in the 30 days prior to study enrollment

Show all 11Show fewer

Blood donation within the past 8 weeks
Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months
Known allergy to varenicline or taking H2blockers
Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol
Subjects likely to exhibit clinically significant alcohol withdrawal during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory
New Haven, Connecticut, 06519

Other trials in United States

About this study

Conditions: Alcohol Reactivity
Being tested: varenicline, placebo
Keywords: alcohol, reactivity, smoking cessation medications

What participants receive

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

vareniclineDrug
Also called Chantix
1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.
placeboDrug
placebo

Study groups in NCT01000987
Study group	Role	What they receive
varenicline	Experimental	varenicline 1mg/day or 2mg/day Receives: Drug: varenicline
placebo	Placebo comparator	placebo Receives: Drug: placebo

What is being measured

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

Cognitive Function as Measured by Omissions on the CPT
Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with "stop" and "go" targets that appear on a computer screen. They are told to press the space bar (respond) to "go" targets and to avoid pressing the space bar when "stop" targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324).
Measured: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.

Timeline

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

Oct 2009Nov 2016

First posted23 Oct 2009 (estimated)
Study startOct 2009
Primary completionNov 2016
Study completionNov 2016

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 Alcohol ReactivityStudies 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: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01000987
Sponsor's protocol ID: 0907005525
Status last verified: Jan 2018
First submitted: 22 Oct 2009
Last updated: 19 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Sensory and Physical Reactions to Beverage Cues
Alcohol Use Disorder (AUD)
Recruiting
Exploring the Effects of Brief Mindfulness Training With Vagal Nerve Stimulation on Alcohol Cue Reactivity Among Young Adult Heavy Drinkers
Heavy Drinking
Recruiting
Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder
Alcohol Use Disorder, Stress Reaction
Not yet recruiting
Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use
Alcohol Use Disorder, Alcoholism

All Alcohol Reactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
ClinicalTrials.gov ID: NCT01000987
Acronym / sponsor ID: 0907005525
Conditions: Alcohol Reactivity
Keywords: alcohol, reactivity, smoking cessation medications
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Study start: Oct 2009
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 23 Oct 2009 (estimated)
Results: Posted 19 Feb 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
varenicline	Experimental	Drug: vareniclinevarenicline 1mg/day or 2mg/day
placebo	Placebo comparator	Drug: placeboplacebo

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

21 years old or older
Able to read and write in English
Smokers and nonsmokers
Meet criteria for alcohol use disorders
Currently enrolled in NCT00580645

Key exclusion criteria (11 listed)

Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
Significant hepatocellular injury
Positive test results at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
Women who are pregnant or nursing
Suicidal, homicidal, or evidence of severe mental illness

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
vareniclineAlso: Chantix1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.	Drug	varenicline
placeboplacebo	Drug	placebo

Primary outcome

Cognitive Function as Measured by Omissions on the CPT
Time frame: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.
Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with "stop" and "go" targets that appear on a computer screen. They are told to press the space bar (respond) to "go" targets and to avoid pressing the space bar when "stop" targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324).

Results and safety

Results posted to the registry on 19 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 mg/Day Varenicline	12	12
2 mg/Day Varenicline	15	15
Placebo	17	17

Primary outcome: Cognitive Function as Measured by Omissions on the CPT

Time frame: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.. Mean (Standard Error). Unit: Number of Omissions

Measure	1 mg/Day Varenicline n = 12	2 mg/Day Varenicline n = 15	Placebo n = 17
Alcohol	1.78 (1.24)	1.28 (1.11)	4.76 (1.05)
Control Beverage	0.98 (1.24)	0.62 (1.11)	2.37 (1.05)

Adverse events

Time frame: During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 mg/Day Varenicline	0 of 20 (0%)	4 of 20 (20%)	0 of 20
2 mg/Day Varenicline	0 of 20 (0%)	5 of 20 (25%)	0 of 20
Placebo	0 of 20 (0%)	7 of 20 (35%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Alcohol Reactivity

Recruiting
Sensory and Physical Reactions to Beverage Cues
Alcohol Use Disorder (AUD)
Recruiting
Exploring the Effects of Brief Mindfulness Training With Vagal Nerve Stimulation on Alcohol Cue Reactivity Among Young Adult Heavy Drinkers
Heavy Drinking
Recruiting
Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder
Alcohol Use Disorder, Stress Reaction
Not yet recruiting
Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use
Alcohol Use Disorder, Alcoholism

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.

Sherry A McKee, PhD 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 Phase 2 study testing varenicline in people with Alcohol Reactivity, 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 11 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 19 Feb 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Feb 2018). 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?

Cognitive Function as Measured by Omissions on the CPT (time frame: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.). 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 NCT01000987.

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 19 Feb 2018.