NCT00861146

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

March 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 7, 2014

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

3.9 years

First QC Date

March 11, 2009

Results QC Date

January 15, 2014

Last Update Submit

April 1, 2020

Conditions

Tobacco Use CessationAlcohol-related Disorders

Keywords

nicotine dependencetobacco dependencesmoking cessationalcoholismself-efficacyrelapse

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Proportion of Days Heavy Drinking

    follow-up weeks 9-12

Study Arms (2)

1 concurrent smoking cessation

EXPERIMENTAL

smoking cessation delivered concurrent with intensive alcohol treatment

Behavioral: behavioral counseling plus contingency management

2 deferred smoking cessation

ACTIVE COMPARATOR

smoking cessation delivered 12 weeks after intensive alcohol treatment

Behavioral: behavioral counseling plus contingency management

Interventions

behavioral counseling plus contingency managementBEHAVIORAL

Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum

1 concurrent smoking cessation2 deferred smoking cessation

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Connecticut Healthcare System

Newington, Connecticut, 06111, United States

Location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • 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.

    PMID: 25622198DERIVED

MeSH Terms

Conditions

Tobacco Use CessationAlcohol-Related DisordersTobacco Use DisorderSmoking CessationAlcoholismRecurrence

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Ned L. Cooney, PhD
Organization
Yale University School of Medicine
ned.cooney@yale.edu
860-594-6339

Study Officials

  • Ned L Cooney, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 13, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 3, 2020

Results First Posted

April 7, 2014

Record last verified: 2020-04

Locations

US(2)