Official Title: “Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: 21mg transdermal nicotine patch (Nicoderm CQ)
  • 21mg transdermal nicotine patch
• Drug: 1mg nicotine nasal spray
  • two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.
• Drug: placebo nasal spray
  • saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: patch+spray
  • Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.
• Placebo Comparator: patch+placebo spray
  • Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.

Primary Measures

• Number of drinks consumed during an ad-lib period
  • Time Frame: during the laboratory sessions
    Safety Issue?: No

Secondary Measures

• craving for alcohol and tobacco
  • Time Frame: during the laboratory sessions
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Sherry A McKee, PhD Principal Investigator Yale University  

Overall Contact: Erika Balchunas 203-737-2783 

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699556

Study ID Number: HIC0508000486

ClinicalTrials.gov Identifier: NCT00699556

Health Authority: United States: Institutional Review Board