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

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ClinicalTrials.gov Identifier: NCT00699556
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

December 25, 2007
June 18, 2008
November 20, 2017
March 12, 2018
March 12, 2018
January 2006
November 2016   (Final data collection date for primary outcome measure)
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.
Number of drinks consumed during an ad-lib period [ Time Frame: during the laboratory sessions ]
Complete list of historical versions of study NCT00699556 on ClinicalTrials.gov Archive Site
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.
craving for alcohol and tobacco [ Time Frame: during the laboratory sessions ]
Not Provided
Not Provided
 
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Drinking
  • Drug: 21mg transdermal nicotine patch (Nicoderm CQ)
    21mg transdermal nicotine patch
    Other Name: Nicoderm CQ
  • 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.
  • 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.
  • Experimental: patch+spray
    Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.
    Interventions:
    • Drug: 21mg transdermal nicotine patch (Nicoderm CQ)
    • Drug: 1mg nicotine nasal spray
  • Placebo Comparator: patch+placebo spray
    Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.
    Interventions:
    • Drug: 21mg transdermal nicotine patch (Nicoderm CQ)
    • Drug: placebo nasal spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
76
November 2016
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00699556
HIC0508000486
R01AA015596 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Sherry McKee, Yale University
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Sherry A McKee, PhD Yale University
Yale University
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP