NCT00000454

Brief Summary

This study is designed to increase understanding of the processes that affect the treatment outcome of individuals with both alcohol and nicotine dependence. Treatment outcome methodology will be combined with a computerized self-monitoring methodology to examine the extent to which smoking serves as a cue for alcohol craving and/or as a response to alcohol craving in treated alcoholics. Subjects will be veterans participating in the Substance Abuse Day Programs at the Newington and West Haven campuses of the VA Connecticut Healthcare System. Nonveteran women will be recruited from the community and enrolled in the day program. Subjects will be randomly assigned to one of the following two conditions: (1) intensive smoking cessation therapy (counseling plus nicotine replacement using nicotine patches) concurrent with alcohol treatment, or (2) brief smoking cessation advice concurrent with alcohol treatment.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for phase_4

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

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
Last Updated

May 19, 2010

Status Verified

May 1, 2010

First QC Date

November 2, 1999

Last Update Submit

May 18, 2010

Conditions

AlcoholismSmoking

Interventions

nicotine replacement patchDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for alcohol dependence within the past three months, and criteria for nicotine dependence.
  • Smoking at least 10 or more cigarettes per day for the past year.
  • Seeking treatment for both alcohol and nicotine dependence.
  • Minimum 1 week of alcohol abstinence and substance abuse day treatment attendance.
  • Willing to provide names of two individuals who can help locate the subject at follow-up.
  • Willing to provide name of one individual who can provide collateral information about alcohol and tobacco use.

You may not qualify if:

  • Other substance use disorder meeting criteria for dependence.
  • Acute medical or psychiatric disorder requiring inpatient treatment.
  • Taking medications known to influence alcohol urges (naltrexone, disulfiram).
  • Medical problems that would contraindicate nicotine patch use.
  • Allergy or hypersensitivity to nicotine or to adhesives used in transdermal delivery systems.
  • Use of other nicotine products such as cigars, pipes, or smokeless tobacco.
  • Severe generalized skin disorder.
  • Myocardial infarction within 3 months prior to study entry.
  • Unstable angina.
  • Pregnant or lactating females, or females who are not practicing a medically accepted form of contraception.
  • Impaired vision or hearing which would interfere with using a hand-held computer.
  • Reading ability below fifth grade level.
  • Lack of reliable transportation to the treatment site, or living more than 1 hour from treatment site.
  • Homeless or unstable residence.
  • Plan for future admission to residential treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Abuse Treatment Center, VA Medical Center

West Haven, Connecticut, 06516, United States

Location

Related Publications (2)

  • Cooney NL, Litt MD, Cooney JL, Pilkey DT, Steinberg HR, Oncken CA. Concurrent brief versus intensive smoking intervention during alcohol dependence treatment. Psychol Addict Behav. 2007 Dec;21(4):570-5. doi: 10.1037/0893-164X.21.4.570.

    PMID: 18072840RESULT

  • Cooney NL, Litt MD, Cooney JL, Pilkey DT, Steinberg HR, Oncken CA. Alcohol and tobacco cessation in alcohol-dependent smokers: analysis of real-time reports. Psychol Addict Behav. 2007 Sep;21(3):277-86. doi: 10.1037/0893-164X.21.3.277.

    PMID: 17874878RESULT

MeSH Terms

Conditions

AlcoholismSmoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Completion

August 1, 2002

Last Updated

May 19, 2010

Record last verified: 2010-05

Locations

US(1)