Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy - Full Text View

Sponsor:	Yale University
Information provided by (Responsible Party):	Sherry McKee, Yale University
ClinicalTrials.gov Identifier:	NCT00699556

Purpose

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.

Condition	Intervention	Phase
Alcohol Drinking	Drug: 21mg transdermal nicotine patch (Nicoderm CQ) Drug: 1mg nicotine nasal spray Drug: placebo nasal spray	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Quitting Smoking Smoking

Drug Information available for: Ethanol Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	76
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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.
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 Name: 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699556

Locations

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

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Sherry A McKee, PhD

Yale University

More Information

No publications provided

Responsible Party:	Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier:	NCT00699556 History of Changes
Other Study ID Numbers:	HIC0508000486, R01AA015596-01
Study First Received:	December 25, 2007
Last Updated:	January 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

alcohol
nicotine
smoking cessation
smoking cessation medications

Additional relevant MeSH terms:

Alcohol Drinking
Smoking
Drinking Behavior
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012