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

Phase 2

Completed

Interventions: Drug: 21mg transdermal nicotine patch (Nicoderm CQ)
Drug: 1mg nicotine nasal spray
Drug: placebo nasal spray

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 behavior.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
patch+spray	1mg nicotine nasal spray	Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.
patch+spray	21mg transdermal nicotine patch (Nicoderm CQ)	Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.
patch+placebo spray	21mg transdermal nicotine patch (Nicoderm CQ)	Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.
patch+placebo spray	placebo nasal spray	Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Craving for Alcohol	first measurement during laboratory session (+60 minutes after beginning of laboratory session)	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.