Combination Nicotine Replacement for Alcoholic Smokers

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00064844
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 96
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The overall objective of the study is to develop recommendations for treatment programs to help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco treatment program. The 175 patients will be divided into two groups. One group will receive an active nicotine patch and active nicotine gum. The other group will receive an active nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year from the beginning of treatment.

Condition or Disease	Intervention/Treatment	Phase
Smoking; Alcoholism	Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation; Drug: Nicoderm CQ nicotine patch; Drug: Placebo gum; Drug: Nicotine gum - Nicorette®	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Combination Nicotine Replacement for Alcoholic Smokers
• Study Start Date: Aug 1, 2002
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Nicotine patch plus placebo gum 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. 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.	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.
Active Comparator: Nicotine patch plus active gum 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. 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.	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: 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.

Outcome Measures

Primary Outcome Measures

1. 6 Month Smoking Abstinence [6 months after smoking quit date]

   Percentage of participants with prolonged carbon monoxide verified smoking abstinence

2. 12 Month Smoking Abstinence [12 months after smoking quit date]

   Percentage of participants with prolonged carbon monoxide verified smoking abstinence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Males and females at least 18 years old.

• English speaking.

• Meets criteria for alcohol dependence or alcohol abuse.

• Must complete an alcohol detoxification program prior to entering the study.

• Currently smoking 15 or more cigarettes per day and have at least a 3 year history of smoking.

• Have a current desire to stop smoking and stop drinking.

• Willing to complete followup assessments up to 12 months after treatment.

• Willing to provide names of 2 people who can help locate the subject at followup and the name of one person who can verify information about alcohol and tobacco use.

• One person per household.

Exclusion Criteria:

• Allergy to nicotine patch or nicotine gum.

• Weigh less than 100 pounds.

• Use other nicotine products, such as cigars, pipes or smokeless tobacco.

• Severe skin disorder.

• Active peptic ulcer.

• Active joint disease.

• Heart attack within 3 months prior to entering the study.

• Pregnant or breastfeeding female who are not on birth control.

• Currently taking medication to treat alcoholism or smoking, such as naltrexone, disulfiram or bupropion.

• Poor vision or hearing that would interfere with using a cell phone.

• Lack of transportation to the treatment site or live at least one hour from the treatment site.

• Homeless.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System	Newington	Connecticut	United States	06111

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ned Cooney, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cooney NL, Cooney JL, Perry BL, Carbone M, Cohen EH, Steinberg HR, Pilkey DT, Sevarino K, Oncken CA, Litt MD. Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum. Addiction. 2009 Sep;104(9):1588-96. doi: 10.1111/j.1360-0443.2009.02624.x. Epub 2009 Jun 22.
• Holt LJ, Litt MD, Cooney NL. Prospective analysis of early lapse to drinking and smoking among individuals in concurrent alcohol and tobacco treatment. Psychol Addict Behav. 2012 Sep;26(3):561-72. doi: 10.1037/a0026039. Epub 2011 Oct 24.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00064844
• Other Study ID Numbers: NIAAACOO11197-05; R01AA011197
• First Posted: Jul 15, 2003
• Last Update Posted: Aug 13, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Yale University: Smoking; Alcoholism
• Additional relevant MeSH terms: Alcoholism; Nicotine

Study Results

Participant Flow

Recruitment Details	96 men and women were randomized to treatment at the Newington and West Haven campuses of the Veterans Affairs (VA) Connecticut Healthcare System.

Arm/Group Title	Nicotine Patch Plus Active Gum	Nicotine Patch Plus Placebo Gum
Arm/Group Description
Period Title: Overall Study
STARTED	45	51
2 Week Follow-up	45	51
3 Month Follow-up	40	47
6 Month Follow-up	39	40
12 Month Follow-up	37	32
COMPLETED	37	32
NOT COMPLETED	8	19

Baseline Characteristics

Arm/Group Title	Nicotine Patch Plus Active Gum	Nicotine Patch Plus Placebo Gum	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	45	51	96
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.1 (10.2)	44.8 (10.1)	44.9 (10.1)
Sex: Female, Male (Count of Participants)
Female	13 28.9%	14 27.5%	27 28.1%
Male	32 71.1%	37 72.5%	69 71.9%
Region of Enrollment (participants) [Number]
United States	45 100%	51 100%	96 100%

Outcome Measures

1. Primary Outcome

Title	6 Month Smoking Abstinence
Description	Percentage of participants with prolonged carbon monoxide verified smoking abstinence
Time Frame	6 months after smoking quit date

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nicotine Patch Plus Active Gum	Nicotine Patch Plus Placebo Gum
Arm/Group Description
Measure Participants	39	40
Number [percentage of participants abstinent]	20 44.4%	12 23.5%

2. Primary Outcome

Title	12 Month Smoking Abstinence
Description	Percentage of participants with prolonged carbon monoxide verified smoking abstinence
Time Frame	12 months after smoking quit date

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nicotine Patch Plus Active Gum	Nicotine Patch Plus Placebo Gum
Arm/Group Description
Measure Participants	37	32
Number [percentage of participants abstinent]	13 28.9%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nicotine Patch Plus Active Gum, Nicotine Patch Plus Placebo Gum
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Chi-squared
	Comments	df = 1, N = 96
Method of Estimation	Estimation Parameter	chi square
	Estimated Value	7.25
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Nicotine Patch Plus Active Gum		Nicotine Patch Plus Placebo Gum
Arm/Group Description
All Cause Mortality
	Nicotine Patch Plus Active Gum		Nicotine Patch Plus Placebo Gum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nicotine Patch Plus Active Gum		Nicotine Patch Plus Placebo Gum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Nicotine Patch Plus Active Gum		Nicotine Patch Plus Placebo Gum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/45 (2.2%)		7/51 (13.7%)
General disorders
bleeding gums	1/45 (2.2%)	1	7/51 (13.7%)	7
jaw ache	0/45 (0%)	0	5/51 (9.8%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.