Condition:
The purpose of this study is the examine the effect of varenicline on reactivity to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.
Dates: October 2009 -
Study Status: Recruiting
Ages Eligible: 21 Years and older
Gender Eligible: Both
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sponsor:
Phase: Phase 2
First Received: October 22, 2009
Last Updated: Oct 26, 2009
Clinicaltrials.gov ID:
NCT01000987
Study HIC # 0907005525
Condition:
Interventions: Drug: varenicline;
Drug: placebo
The purpose of this study is the examine the effect of varenicline on reactivity to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.
Dates: October 2009 -
Study Status: Recruiting
Ages Eligible: 21 Years and older
Gender Eligible: Both
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sponsor:
Phase: Phase 2
First Received: October 22, 2009
Last Updated: Oct 26, 2009
Clinicaltrials.gov ID:
NCT01000987
Study HIC # 0907005525
Erika Balchunas
203-737-2783
Sherry A McKee, PhD
Principal Investigator
HIC # 0805003779
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