Condition:
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.
Dates: January 2006 -
Study Status: Recruiting
Ages Eligible: 21 Years and older
Gender Eligible: Both
Inclusion Criteria:
- Ages 21 and over
- Able to read and write in English
- Smoker
- Heavy drinker
Exclusion Criteria:
- Any significant current medical or psychiatric conditions that would contraindicate
the consumption of alcohol or nicotine
- Significant hepatocellular injury
- Positive test result 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 who have attempted to
quit drinking or smoking within the past 3 months
- Specific exclusions for administration of nicotine nasal spray not specified above
including nasal polyps, chronic nasal congestion, allergies, sinusitis
- Specific exclusions for administration of nicotine patch not specified above
including history of dermatoses
- Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior
adverse reaction to nicotine spray
- 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 study
Sponsor:
Phase: Phase 2
First Received: December 25, 2007
Last Updated: October 22, 2009
Clinicaltrials.gov ID:
NCT00699556
Study HIC # 0508000486
Condition:
Interventions: Drug: 21mg transdermal nicotine patch (Nicoderm CQ);
Drug: 1mg nicotine nasal spray;
Drug: placebo nasal spray
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.
Dates: January 2006 -
Study Status: Recruiting
Ages Eligible: 21 Years and older
Gender Eligible: Both
Inclusion Criteria:
- Ages 21 and over
- Able to read and write in English
- Smoker
- Heavy drinker
Exclusion Criteria:
- Any significant current medical or psychiatric conditions that would contraindicate
the consumption of alcohol or nicotine
- Significant hepatocellular injury
- Positive test result 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 who have attempted to
quit drinking or smoking within the past 3 months
- Specific exclusions for administration of nicotine nasal spray not specified above
including nasal polyps, chronic nasal congestion, allergies, sinusitis
- Specific exclusions for administration of nicotine patch not specified above
including history of dermatoses
- Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior
adverse reaction to nicotine spray
- 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 study
Sponsor:
Phase: Phase 2
First Received: December 25, 2007
Last Updated: October 22, 2009
Clinicaltrials.gov ID:
NCT00699556
Study HIC # 0508000486
Erika Balchunas
203-737-2783
McKee, Sherry
Principal Investigator
HIC # 0805003779
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