Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00861146
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 151
• Locations: 2
• Arms: 2
• Duration (Months): 47
• Patients Per Site: 75.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The majority of individuals with alcohol problems remain current smokers, and the negative health consequences of smoking among these individuals are substantial. This study will investigate the impact of smoking cessation interventions initiated during intensive alcohol treatment on processes reflecting risk of alcohol relapse.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Cessation; Alcohol-related Disorders	Behavioral: behavioral counseling plus contingency management	Phase 2

Detailed Description

Objectives:

Most alcohol and drug treatment programs do not systematically address cigarette smoking during treatment. One obstacle is a concern that smoking cessation early in recovery might increase risk of alcohol relapse. This study followed patients enrolled in intensive outpatient alcohol treatment to compare the effects of a Concurrent Smoking Cessation (CSC) intervention to a Deferred Smoking Cessation (DSC) control group on process measures reflecting risk of alcohol relapse.

Research Design:

Participants were enrolled in intensive outpatient alcohol treatment and then randomized to CSC or DSC groups in a 2:1 ratio. The CSC group received smoking treatment concurrent with intensive alcohol treatment and the DSC group received smoking treatment three months after alcohol treatment. The smoking treatment protocol included behavioral counseling, contingency management with voucher rewards for verified smoking abstinence, and prescribed nicotine patch and gum. During a three-month period after the CSC target smoking quit date, both groups of subjects were asked to participate in a prospective daily monitoring procedure, calling into an Interactive Voice Response system once a day to complete self-report assessments of relapse risk factors. By comparing participants in the CSC group composed of many participants who have stopped smoking with the DSC group who are expected to continue smoking during this daily monitoring period, we will determine the impact of smoking cessation on alcohol relapse risk factors.

Methodology:

This study was conducted in the substance abuse day treatment programs located at Newington and West Haven campuses of VA Connecticut Healthcare System. These are three-week treatment programs meeting Monday-Friday for 4-5 hrs/day. Participants were recruited either before or soon after day program admission. Participants 151 individuals that are 18 years of age or older, meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol abuse or dependence, report currently smoking 1 or more cigarettes per day, and are screened for medical contraindications for nicotine patch and gum use. Dependent variables are process assessments reflecting alcohol relapse risk obtained using daily Interactive Voice Response (IVR) technology. These relapse risk processes include alcohol craving, negative affect, alcohol abstinence self efficacy, alcohol outcome expectancies, motivation for alcohol abstinence, and self-control demands. Given the mixed results from previous clinical trials, we conducted bidirectional tests of the hypothesis that smoking cessation has an impact on alcohol relapse risk factors, examining whether smoking cessation leads to increased or decreased alcohol relapse risk.

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 concurrent smoking cessation smoking cessation delivered concurrent with intensive alcohol treatment	Behavioral: behavioral counseling plus contingency management; Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
Active Comparator: 2 deferred smoking cessation smoking cessation delivered 12 weeks after intensive alcohol treatment	Behavioral: behavioral counseling plus contingency management; Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum

Outcome Measures

Primary Outcome Measures

1. Smoking Abstinence [12 weeks]

   7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking

2. Smoking Abstinence [2 weeks]

   7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking

Secondary Outcome Measures

1. Proportion of Days Heavy Drinking [follow-up weeks 9-12]

   Heavy drinking days were defined as days with > 6 standard drinks per day for men and > 4 standard drinks per day for women. This measure examined the proportion of days heavy drinking across 28 days in follow-up weeks 9-12.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• DSM-IV criteria for alcohol abuse or dependence

• Age 18 or older

• English speaking

• Smoking 1 or more cigarettes/day

• Male or female veterans eligible for VA healthcare

• Female nonveterans also eligible

Exclusion Criteria:

• Allergy or hypersensitivity to nicotine or adhesives used in nicotine patch

• Weigh less than 100 lbs

• Lack of interest in stopping smoking

• Pregnant or lactating females or females not practicing acceptable form of contraception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System	Newington	Connecticut	United States	06111
2	VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ned L Cooney, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00861146
• Other Study ID Numbers: 0804003723; R01AA011197
• First Posted: Mar 13, 2009
• Last Update Posted: Apr 3, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Yale University: nicotine dependence; tobacco dependence; smoking cessation; alcoholism; self-efficacy; relapse
• Additional relevant MeSH terms: Recurrence; Alcohol-Related Disorders

Study Results

Participant Flow

Recruitment Details	Enrollment May 2009 to October 2012. Excluded (n=1448): Does not smoke, does not drink (n=678) Declined to participate (n=320) Medical problems (n=297) Otherwise ineligible (n=112) Male non-vet (n=41)

Arm/Group Title	1 Concurrent Smoking Cessation	2 Deferred Smoking Cessation
Arm/Group Description	smoking cessation delivered concurrent with intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum	smoking cessation delivered 12 weeks after intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
Period Title: Overall Study
STARTED	105	46
Week 2 Assessment	97	45
Week 13 Assessment	85	38
COMPLETED	85	38
NOT COMPLETED	20	8

Baseline Characteristics

Arm/Group Title	1 Concurrent Smoking Cessation	2 Deferred Smoking Cessation	Total
Arm/Group Description	smoking cessation delivered concurrent with intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum	smoking cessation delivered 12 weeks after intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum	Total of all reporting groups
Overall Participants	105	46	151
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.5 (9.07)	48.1 (8.68)	49.1 (8.95)
Sex: Female, Male (Count of Participants)
Female	14 13.3%	7 15.2%	21 13.9%
Male	91 86.7%	39 84.8%	130 86.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	43 41%	20 43.5%	63 41.7%
White	57 54.3%	25 54.3%	82 54.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	5 4.8%	1 2.2%	6 4%
Region of Enrollment (participants) [Number]
United States	105 100%	46 100%	151 100%
Cigarettes smoked/day (cigarettes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cigarettes]	16.0 (8.0)	16.8 (10.0)	16.2 (8.7)
Proportion days heavy drinking (proportion) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [proportion]	.58 (.33)	.52 (.38)	.56 (.35)

Outcome Measures

1. Primary Outcome

Title	Smoking Abstinence
Description	7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 Concurrent Smoking Cessation	2 Deferred Smoking Cessation
Arm/Group Description	smoking cessation delivered concurrent with intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum	smoking cessation delivered 12 weeks after intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
Measure Participants	105	46
Number [participants]	20 19%	1 2.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1 Concurrent Smoking Cessation, 2 Deferred Smoking Cessation
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<.01
	Comments
	Method	Chi-squared
	Comments	df = 1

2. Secondary Outcome

Title	Proportion of Days Heavy Drinking
Description	Heavy drinking days were defined as days with > 6 standard drinks per day for men and > 4 standard drinks per day for women. This measure examined the proportion of days heavy drinking across 28 days in follow-up weeks 9-12.
Time Frame	follow-up weeks 9-12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 Concurrent Smoking Cessation	2 Deferred Smoking Cessation
Arm/Group Description	smoking cessation delivered concurrent with intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum	smoking cessation delivered 12 weeks after intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
Measure Participants	85	38
Mean (Standard Deviation) [proportion of days]	.0332 (.1130)	.0132 (.0375)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1 Concurrent Smoking Cessation, 2 Deferred Smoking Cessation
	Comments	Drinking outcomes assessed using the timeline follow-back were evaluated with mixed model regression analyses using maximum likelihood estimation. Time was measured in three monthly periods and treated as a repeated factor (due to the fixed time period between estimates).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	> .15
	Comments
	Method	mixed model regression analyses
	Comments
Method of Estimation	Estimation Parameter	mixed model regression analyses (F)
	Estimated Value	2.04
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Smoking Abstinence
Description	7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 Concurrent Smoking Cessation	2 Deferred Smoking Cessation
Arm/Group Description	smoking cessation delivered concurrent with intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum	smoking cessation delivered 12 weeks after intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
Measure Participants	105	46
Number [participants]	53 50.5%	1 2.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1 Concurrent Smoking Cessation, 2 Deferred Smoking Cessation
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Chi-squared
	Comments	df=1

Adverse Events

Arm/Group Title	1 Concurrent Smoking Cessation		2 Deferred Smoking Cessation
Arm/Group Description	smoking cessation delivered concurrent with intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum		smoking cessation delivered 12 weeks after intensive alcohol treatment behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
All Cause Mortality
	1 Concurrent Smoking Cessation		2 Deferred Smoking Cessation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1 Concurrent Smoking Cessation		2 Deferred Smoking Cessation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/105 (3.8%)		2/46 (4.3%)
Gastrointestinal disorders
Hospitalization gastrointestinal	0/105 (0%)	0	1/46 (2.2%)	1
Nervous system disorders
Hospitalization stroke	1/105 (1%)	1	1/46 (2.2%)	1
Psychiatric disorders
Hospitalization psychiatric	2/105 (1.9%)	2	1/46 (2.2%)	1
Hospitalization alcohol	1/105 (1%)	1	0/46 (0%)	0
Other (Not Including Serious) Adverse Events
	1 Concurrent Smoking Cessation		2 Deferred Smoking Cessation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	60/105 (57.1%)		12/46 (26.1%)
Gastrointestinal disorders
dry mouth	19/105 (18.1%)	19	3/46 (6.5%)	3
heartburn or indigestion	8/105 (7.6%)	8	1/46 (2.2%)	1
Psychiatric disorders
vivid dreams	32/105 (30.5%)	32	7/46 (15.2%)	7
insomnia	8/105 (7.6%)	8	1/46 (2.2%)	1
Respiratory, thoracic and mediastinal disorders
coughing	14/105 (13.3%)	14	3/46 (6.5%)	3
hiccups	6/105 (5.7%)	6	2/46 (4.3%)	2
Skin and subcutaneous tissue disorders
itching or irritation	30/105 (28.6%)	30	5/46 (10.9%)	5
rash	7/105 (6.7%)	7	2/46 (4.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.