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Advancing Tobacco and Cancer Control: Reducing Alcohol Use to Promote Smoking Cessation

Phase 1/Phase 2
18 Years
Not Enrolling
Smoking, Nicotine Dependence, Alcohol Dependence

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Trial Information

Advancing Tobacco and Cancer Control: Reducing Alcohol Use to Promote Smoking Cessation

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
1,948 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 quitdate and 7-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.

Inclusion Criteria:

- Adults (18+ years)

- Cigarette smokers requesting assistance with quitting smoking

- Hazardous drinkers (per NIAAA criteria)

Exclusion Criteria:

- Eligible for Enhanced Services Program

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Efficacy of advice to limit or abstain from alcohol use in improving smoking cessation.

Outcome Description:

To determine if advice to limit or abstain from alcohol use results in improved smoking cessation outcomes in 1,950 smokers who drink at hazardous levels and are calling a telephone Quitline.

Outcome Time Frame:

6 Months

Safety Issue:


Principal Investigator

Benjamin A. Toll, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University


United States: Institutional Review Board

Study ID:

NCI R01 CA140256-01A1



Start Date:

January 2011

Completion Date:

May 2012

Related Keywords:

  • Smoking
  • Nicotine Dependence
  • Alcohol Dependence
  • Smoking
  • Tobacco
  • Drinking
  • Alcoholism
  • Tobacco Use Disorder
  • Smoking



Roswell Park Cancer InstituteBuffalo, New York  14263