NCT01120080

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,948

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 2, 2020

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

April 26, 2010

Last Update Submit

March 31, 2020

Conditions

SmokingNicotine DependenceAlcohol Dependence

Keywords

SmokingTobaccoDrinking

Outcome Measures

Primary Outcomes (1)

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

    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.

    6 Months

Secondary Outcomes (3)

  • Efficacy of advice to limit or abstain from alcohol use.

    6 Months

  • Does reductions in alcohol use mediate smoking cessation success

    6 Months

  • What factors that determine smoking cessation success also determine who is more likely to respond to the alcohol intervention

    6 Months

Study Arms (2)

Practical Counseling

PLACEBO COMPARATOR
Behavioral: Practical Counseling

Alcohol Intervention Counseling

ACTIVE COMPARATOR
Behavioral: Alcohol Intervention Counseling

Interventions

Practical CounselingBEHAVIORAL

To ensure that treatment effects are not due to the longer counseling intervention and additional alcohol intervention workbook in the Alcohol Intervention plus Standard Care condition, we will provide additional smoking cessation advice that will not be specific to alcohol use and an additional smoking cessation workbook for participants in the Practical Counseling plus Standard Care condition. Consistent with the Clinical Practice Guideline Update, we will include 5 minutes of practical counseling, which has been shown empirically to be effective in improving rates of smoking cessation.

Practical Counseling
Alcohol Intervention CounselingBEHAVIORAL

The Alcohol Intervention counseling protocol will be adapted from Dr. Ockene's brief alcohol intervention protocol and Dr. Kahler's brief alcohol intervention for smokers: Feedback and discussion on the relationship between drinking and smoking, and on the potential effects of alcohol consumption on smoking cessation; an emphasis on personal Responsibility for choosing to change one's behavior; Advice to avoid or minimize drinking during the smoking cessation process; a Menu of options for carrying out a change strategy; use of Empathy by the clinician; and encouragement of Self-efficacy (i.e., confidence) for successful change.

Alcohol Intervention Counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18+ years)
  • Cigarette smokers requesting assistance with quitting smoking
  • Hazardous drinkers (per NIAAA criteria)

You may not qualify if:

  • Eligible for Enhanced Services Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (1)

  • Toll BA, Martino S, O'Malley SS, Fucito LM, McKee SA, Kahler CW, Rojewski AM, Mahoney MC, Wu R, Celestino P, Seshadri S, Koutsky J, Hyland A, Cummings KM. A randomized trial for hazardous drinking and smoking cessation for callers to a quitline. J Consult Clin Psychol. 2015 Jun;83(3):445-54. doi: 10.1037/a0038183. Epub 2014 Nov 24.

    PMID: 25419583DERIVED

MeSH Terms

Conditions

SmokingTobacco Use DisorderAlcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Benjamin A. Toll, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

May 10, 2010

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 2, 2020

Record last verified: 2013-01

Locations

US(1)