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

Yale University

Status and phase: Completed; Phase 2

Conditions: Alcohol Drinking

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00699556

R01AA015596 (U.S. NIH Grant/Contract)

HIC0508000486

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

patch+spray

Experimental group

Description:

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

Treatment:

Drug: 21mg transdermal nicotine patch (Nicoderm CQ)

Drug: 1mg nicotine nasal spray

patch+placebo spray

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo nasal spray

Drug: 21mg transdermal nicotine patch (Nicoderm CQ)