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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Drinking

In brief

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.

Key facts

Study ID

NCT00699556

Run by

Yale University

People needed

22

Starts

2006-01-01

Expected to finish

2016-11-01

Last updated by the study team

2018-03-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 21 and over
• Able to read and write in English
• Smoker
• Heavy drinker

You may not qualify if…

• 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

Where it is running

• Connecticut Mental Health Center & Yale-New Haven Hospital — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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