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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2016-11-30

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.

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Detailed Description

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Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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patch+spray

Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.

Group Type EXPERIMENTAL

21mg transdermal nicotine patch (Nicoderm CQ)

Intervention Type DRUG

21mg transdermal nicotine patch

1mg nicotine nasal spray

Intervention Type DRUG

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.

patch+placebo spray

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

Group Type PLACEBO_COMPARATOR

21mg transdermal nicotine patch (Nicoderm CQ)

Intervention Type DRUG

21mg transdermal nicotine patch

placebo nasal spray

Intervention Type DRUG

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.

Interventions

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21mg transdermal nicotine patch (Nicoderm CQ)

21mg transdermal nicotine patch

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Nicoderm CQ

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No