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: February 21, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 25, 2007

Last Updated Date

February 21, 2013

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of drinks consumed during an ad-lib period [ Time Frame: during the laboratory sessions ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00699556 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

craving for alcohol and tobacco [ Time Frame: during the laboratory sessions ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Alcohol Drinking

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00699556

Other Study ID Numbers ^ICMJE

HIC0508000486, R01AA015596-01

Has Data Monitoring Committee

Yes

Responsible Party

Sherry McKee, Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sherry A McKee, PhD

Yale University

Information Provided By

Yale University

Verification Date

February 2013

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

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