Overview

This trial has been completed.

Condition alcohol drinking
Treatments 21mg transdermal nicotine patch (nicoderm cq), 1mg nicotine nasal spray, placebo nasal spray
Phase phase 2
Sponsor Yale University
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date January 2006
End date November 2016
Trial size 22 participants
Trial identifier NCT00699556, HIC0508000486, R01AA015596

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.
21mg transdermal nicotine patch (nicoderm cq) Nicoderm CQ
21mg transdermal nicotine patch
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)
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.
21mg transdermal nicotine patch (nicoderm cq) Nicoderm CQ
21mg transdermal nicotine patch
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.

Primary Outcomes

Measure
Number of drinks consumed during an ad-lib period
time frame: during the laboratory sessions

Secondary Outcomes

Measure
craving for alcohol and tobacco
time frame: during the laboratory sessions

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Principal investigator Sherry A McKee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yale University.