Combination Nicotine Replacement for Alcoholic Smokers

PHASE4CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

July 31, 2006

Study Completion Date

July 31, 2006

Conditions
SmokingAlcoholism
Interventions
BEHAVIORAL

Cognitive Behavior Therapy for alcohol and smoking cessation

Individual 60-minute treatment sessions were scheduled weekly for the first 3 months, then monthly for the next 3 months for a total of 16 sessions. Alcohol treatment was based on the cognitive behavioral therapy manual developed for Project MATCH, with approximately 40-45 minutes of each session devoted to alcohol treatment. Components of this intervention included identifying alcohol antecedents, coping with alcohol urges, managing thoughts about alcohol, problem solving, drink refusal skills, planning for emergencies, communication and assertiveness training and enhancing social support networks for alcohol abstinence. The smoking cessation intervention was delivered in the same sessions as the alcohol treatment, with approximately 15-20 minutes of each session devoted to smoking cessation. Treatment employed behavioral elements that have been supported empirically according to the USDHHS smoking cessation practice guideline.

DRUG

Nicoderm CQ nicotine patch

Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy.

DRUG

Placebo gum

Placebo gum was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. The placebo gum (manufactured by Fertin Pharma A/S, Vejle, Denmark) contained 2.6% cayenne pepper to simulate the taste of nicotine. Use of the gum was encouraged for 24 weeks.

DRUG

Nicotine gum - Nicorette®

Nicotine gum (2 mg uncoated mint Nicorette®) was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. Use of the gum was encouraged for 24 weeks.

Trial Locations (1)

06111

VA Connecticut Healthcare System, Newington

All Listed Sponsors
collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

lead

Yale University

OTHER

NCT00064844 - Combination Nicotine Replacement for Alcoholic Smokers | Biotech Hunter | Biotech Hunter