Status:
COMPLETED
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Drinking
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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 b...
Eligibility Criteria
Inclusion
- Ages 21 and over
- Able to read and write in English
- Smoker
- Heavy drinker
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00699556
Start Date
January 1 2006
End Date
November 1 2016
Last Update
March 12 2018
Active Locations (1)
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1
Connecticut Mental Health Center & Yale-New Haven Hospital
New Haven, Connecticut, United States, 06519