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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699556
• Other study ID #: HIC0508000486
• Secondary ID: R01AA015596
• Status: Completed
• Phase: Phase 2
• First received: December 25, 2007
• Last updated: February 12, 2018
• Start date: January 2006
• Est. completion date: November 2016

Study information

• Verified date: February 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Drug:
• 21mg transdermal nicotine patch (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 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.

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center & Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Drinks Consumed During an Ad-libitum Drinking Period	Participants are presented with alcohol beverages and allowed to drink at their leisure.	Two hour ad-libitum drinking period during laboratory session
Secondary	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.	first measurement during laboratory session (+60 minutes after beginning of laboratory session)