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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Nicotine

Criteria

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