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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT00699556
First received: December 25, 2007
Last updated: October 7, 2014
Last verified: October 2014

December 25, 2007
October 7, 2014
January 2006
December 2014   (final data collection date for primary outcome measure)
Number of drinks consumed during an ad-lib period [ Time Frame: during the laboratory sessions ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00699556 on ClinicalTrials.gov Archive Site
craving for alcohol and tobacco [ Time Frame: during the laboratory sessions ] [ Designated as safety issue: No ]
Same as current
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: Double Blind (Subject, 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.
 
Active, not recruiting
76
December 2014
December 2014   (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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00699556
HIC0508000486, R01AA015596-01
Yes
Sherry McKee, Yale University
Yale University
Not Provided
Principal Investigator: Sherry A McKee, PhD Yale University
Yale University
October 2014

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