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

Primary Purpose

Alcohol Drinking

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
21mg transdermal nicotine patch (Nicoderm CQ)
1mg nicotine nasal spray
placebo nasal spray
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring alcohol, nicotine, smoking cessation, smoking cessation medications

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Connecticut Mental Health Center & Yale-New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

patch+spray

patch+placebo spray

Arm Description

Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.

Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.

Outcomes

Primary Outcome Measures

Number of Drinks Consumed During an Ad-libitum Drinking Period
Participants are presented with alcohol beverages and allowed to drink at their leisure.

Secondary Outcome Measures

Craving for Alcohol
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.

Full Information

First Posted
December 25, 2007
Last Updated
February 12, 2018
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00699556
Brief Title
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Official Title
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
alcohol, nicotine, smoking cessation, smoking cessation medications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patch+spray
Arm Type
Experimental
Arm Description
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.
Arm Title
patch+placebo spray
Arm Type
Placebo Comparator
Arm Description
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.
Intervention Type
Drug
Intervention Name(s)
21mg transdermal nicotine patch (Nicoderm CQ)
Other Intervention Name(s)
Nicoderm CQ
Intervention Description
21mg transdermal nicotine patch
Intervention Type
Drug
Intervention Name(s)
1mg nicotine nasal spray
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo nasal spray
Intervention Description
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 Outcome Measure Information:
Title
Number of Drinks Consumed During an Ad-libitum Drinking Period
Description
Participants are presented with alcohol beverages and allowed to drink at their leisure.
Time Frame
Two hour ad-libitum drinking period during laboratory session
Secondary Outcome Measure Information:
Title
Craving for Alcohol
Description
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.
Time Frame
first measurement during laboratory session (+60 minutes after beginning of laboratory session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry A McKee, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center & Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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

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