Alcohol-related Disorders, Tobacco Use Cessation
Conditions
Keywords
nicotine dependence, tobacco dependence, smoking cessation, alcoholism, self-efficacy, relapse
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.
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.
Interventions
BEHAVIORALbehavioral counseling plus contingency management
Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 12 weeks | 7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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)
Participants by arm
| Arm | Count |
|---|---|
| 1 Concurrent Smoking Cessation 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 | 105 |
| 2 Deferred Smoking Cessation 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 | 46 |
| Total | 151 |
Baseline characteristics
| Characteristic | 2 Deferred Smoking Cessation | Total | 1 Concurrent Smoking Cessation |
|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 8.68 | 49.1 years STANDARD_DEVIATION 8.95 | 49.5 years STANDARD_DEVIATION 9.07 |
| Cigarettes smoked/day | 16.8 cigarettes STANDARD_DEVIATION 10 | 16.2 cigarettes STANDARD_DEVIATION 8.7 | 16.0 cigarettes STANDARD_DEVIATION 8 |
| Proportion days heavy drinking | .52 proportion STANDARD_DEVIATION 0.38 | .56 proportion STANDARD_DEVIATION 0.35 | .58 proportion STANDARD_DEVIATION 0.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 63 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) White | 25 Participants | 82 Participants | 57 Participants |
| Region of Enrollment United States | 46 participants | 151 participants | 105 participants |
| Sex: Female, Male Female | 7 Participants | 21 Participants | 14 Participants |
| Sex: Female, Male Male | 39 Participants | 130 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 105 | 12 / 46 |
| serious Total, serious adverse events | 4 / 105 | 2 / 46 |
Outcome results
Primary
Smoking Abstinence
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Concurrent Smoking Cessation | Smoking Abstinence | 20 participants |
| 2 Deferred Smoking Cessation | Smoking Abstinence | 1 participants |
p-value: <0.01Chi-squared
Primary
Smoking Abstinence
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Concurrent Smoking Cessation | Smoking Abstinence | 53 participants |
| 2 Deferred Smoking Cessation | Smoking Abstinence | 1 participants |
p-value: <0.001Chi-squared
Secondary
Proportion of Days Heavy Drinking
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Concurrent Smoking Cessation | Proportion of Days Heavy Drinking | .0332 proportion of days | Standard Deviation 0.113 |
| 2 Deferred Smoking Cessation | Proportion of Days Heavy Drinking | .0132 proportion of days | Standard Deviation 0.0375 |
Comparison: 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).p-value: >0.15mixed model regression analyses