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

NCT00699556 | Completed Phase 2 Results DMC

• 2 other identifiers: HIC0508000486R01AA015596
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Keywords

alcohol; nicotine; smoking cessation; smoking cessation medications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Craving for Alcohol

  first measurement during laboratory session (+60 minutes after beginning of laboratory session)

Study Arms (2)

patch+spray

EXPERIMENTAL

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); Drug: 1mg nicotine nasal spray

patch+placebo spray

PLACEBO COMPARATOR

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); Drug: placebo nasal spray

Interventions

21mg transdermal nicotine patch (Nicoderm CQ) DRUG

21mg transdermal nicotine patch

Also known as: Nicoderm CQ

patch+placebo spray; patch+spray

1mg nicotine nasal spray DRUG

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.

patch+spray

placebo nasal spray DRUG

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.

patch+placebo spray

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 21 and over
• Able to read and write in English
• Smoker
• Heavy drinker

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Connecticut Mental Health Center & Yale-New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Sherry McKee
• Organization: Yale University

sherry.mckee@yale.edu

(203) 737-3529

Study Officials

• Sherry A McKee, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: December 25, 2007
• First Posted: June 18, 2008
• Study Start: January 1, 2006
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 12, 2018
• Results First Posted: March 12, 2018

Record last verified: 2018-02

Locations

US (1)