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

February 12, 2018 updated by: Sherry McKee, Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center & Yale-New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patch+spray
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.
Drug: 21mg transdermal nicotine patch (Nicoderm CQ)
21mg transdermal nicotine patch
Other Names:
  • 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.
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.
Drug: 21mg transdermal nicotine patch (Nicoderm CQ)
21mg transdermal nicotine patch
Other Names:
  • Nicoderm CQ
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two hour ad-libitum drinking period during laboratory session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
first measurement during laboratory session (+60 minutes after beginning of laboratory session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 25, 2007

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIC0508000486
  • R01AA015596 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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