View Clinical Trial (Medical Research Study)
Alcohol Counseling for Telephone Quitline Callers - NCT01120080-14263(Clinical Trial 623967)
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| City: |
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Buffalo |
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State:
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NY |
| Zip Code: |
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14263 |
| Conditions: |
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Smoking - Nicotine Dependence - Alcohol Dependence |
| Purpose: |
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The goal of this study is to train phone counselors working for the New York (NY) State
Smokers' Quitline to advise callers who drink at hazardous levels to limit or abstain from
alcohol use to determine whether this improves smoking cessation outcomes so that we can
establish effect size estimates for a full scale multi-site trial.
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| Study summary: |
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This is a developmental study to: 1) create and beta test an alcohol counseling protocol
with 25 Quitline callers and 2) train Quitline Specialists to provide an alcohol
intervention using at least 100 pilot Quitline callers to ensure that Specialists in the
alcohol intervention + standard care condition provide counseling that addresses hazardous
drinking with a high level of alcohol intervention strategies and skill. After this phase of
the study is complete, a developmental randomized clinical trial will be conducted with
1,950 NY Quitline callers who drink at hazardous levels to compare practical counseling +
smoking cessation print materials added to standard care (PC + SC condition) to alcohol
intervention counseling + alcohol-focused print materials added to standard care (AI + SC
condition). Efficacy data from this trial will be used to determine effect size estimates
for both 1-week and 6-month self-reported point prevalence abstinence rates. Reduction in
alcohol consumption and reduced drinking as a mediator of smoking cessation outcome will be
secondary outcomes. Other mediators and moderators of alcohol intervention effects will also
be examined as an exploratory outcome. If the effect size estimates are sufficiently large
and medically important to pursue a definitive trial, these data will be used to propose a
full scale multi-site large study. If an alcohol intervention is shown to enhance treatment
outcome in a large-scale study, alcohol interventions with quitline counselors could be
translated for use by the entire NY state quitline and other quitlines across the country.
This may increase the effectiveness of quitline interventions and thus has the potential to
reach millions of smokers, thereby bolstering tobacco and cancer control efforts across the
United States. |
| Criteria: |
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Inclusion Criteria:
- Adults (18+ years)
- Cigarette smokers requesting assistance with quitting smoking
- Hazardous drinkers (per NIAAA criteria)
Exclusion Criteria:
- Eligible for Enhanced Services Program |
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| Study is available at: |
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Roswell Park Cancer Institute
Buffalo, NY 14263
United States
Primary Contact:
Shannon Carlin-Menter, Ph.D.
Email: Shannon.CarlinMenter@roswellpark.org
Phone: 716-845-4662 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
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