Skip to main content
OpenTrials
Completed

NCT Number: NCT00699556

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Health Behavior Smoking Cessation

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Connecticut Mental Health Center & Yale-New Haven Hospital

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

21mg transdermal nicotine patch (Nicoderm CQ)

Drug

21mg transdermal nicotine patch

Other names: Nicoderm CQ

1mg nicotine nasal spray

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.

Placebo nasal spray

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.

Primary outcomes

  1. Number of Drinks Consumed During an Ad-libitum Drinking Period

    Time frame: Two hour ad-libitum drinking period during laboratory session

    Participants are presented with alcohol beverages and allowed to drink at their leisure.

Secondary outcomes

  1. Craving for Alcohol

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Jun 18, 2008
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.