Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Drug: 21mg transdermal nicotine patch (Nicoderm CQ)
* Drug: 1mg nicotine nasal spray
* Drug: placebo nasal spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patch+spray<br>Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. | Drug: 21mg transdermal nicotine patch (Nicoderm CQ)<br>* 21mg transdermal nicotine patch<br>* Other names: Nicoderm CQ;Drug: 1mg nicotine nasal spray<br>* 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.<br>|
| Placebo Comparator: patch+placebo spray<br>Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. | Drug: 21mg transdermal nicotine patch (Nicoderm CQ)<br>* 21mg transdermal nicotine patch<br>* Other names: Nicoderm CQ;Drug: placebo nasal spray<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Drinks Consumed During an Ad-libitum Drinking Period | Participants are presented with alcohol beverages and allowed to drink at their leisure. | Two hour ad-libitum drinking period during laboratory session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving for Alcohol | Alcohol craving was measured using the Alcohol Urge Questionnaire (AUQ). The range of scores is 1-100 on a visual analog scale (VAS). Higher scores indicate higher levels of craving. Score indicated is the total score. | first measurement during laboratory session (+60 minutes after beginning of laboratory session) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, nicotine, smoking cessation, smoking cessation medications