Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AA011197 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 concurrent smoking cessation | Experimental | smoking cessation delivered concurrent with intensive alcohol treatment |
|
| 2 deferred smoking cessation | Active Comparator | smoking cessation delivered 12 weeks after intensive alcohol treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral counseling plus contingency management | Behavioral | Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence | 7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking | 12 weeks |
| Smoking Abstinence | 7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | follow-up weeks 9-12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ned L Cooney, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | Newington | Connecticut | 06111 | United States | ||
| VA Connecticut Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25622198 | Derived | Cooney NL, Litt MD, Sevarino KA, Levy L, Kranitz LS, Sackler H, Cooney JL. Concurrent alcohol and tobacco treatment: Effect on daily process measures of alcohol relapse risk. J Consult Clin Psychol. 2015 Apr;83(2):346-58. doi: 10.1037/a0038633. Epub 2015 Jan 26. |
Not provided
Not provided
Not provided
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)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 2 Deferred Smoking Cessation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Abstinence | 7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking | Posted | Number | participants | 12 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization psychiatric | Psychiatric disorders | Non-systematic Assessment | unrelated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vivid dreams | Psychiatric disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ned L. Cooney, PhD | Yale University School of Medicine | 860-594-6339 | ned.cooney@yale.edu |
Not provided
| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D019973 | Alcohol-Related Disorders |
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| D000437 | Alcoholism |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| West Haven |
| Connecticut |
| 06516 |
| United States |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cigarettes smoked/day | Mean | Standard Deviation | cigarettes |
|
| Proportion 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. The baseline measure examined the proportion of heavy drinking days in the 90 days prior to the last day of reported drinking prior to study enrollment. | Mean | Standard Deviation | proportion |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | proportion of days | follow-up weeks 9-12 |
|
|
|
|
| Primary | Smoking Abstinence | 7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking | Posted | Number | participants | 2 weeks |
|
|
|
|
| 4 |
| 105 |
| 60 |
| 105 |
| EG001 | 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 | 2 | 46 | 12 | 46 |
|
| Hospitalization alcohol | Psychiatric disorders | Non-systematic Assessment | unrelated |
|
| Hospitalization stroke | Nervous system disorders | Non-systematic Assessment | unrelated |
|
| Hospitalization gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment | unrelated |
|
| itching or irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| insomnia | Psychiatric disorders | Systematic Assessment |
|
| heartburn or indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |