Phase 2 N=22 Randomized Triple-blind Treatment

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

Alcohol Drinking

Bottom Line

View on ClinicalTrials.gov: NCT00699556 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Number of Drinks Consumed During an Ad-libitum Drinking Period — 1.59; 1.64 drinks

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 21mg transdermal nicotine patch (Nicoderm CQ) (Drug); 1mg nicotine nasal spray (Drug); placebo nasal spray (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Drinks Consumed During an Ad-libitum Drinking Period	1.59; 1.64	—
SECONDARY Craving for Alcohol	14.75; 17.03	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00699556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.