Tobacco Cessation Field Study for Adults in Recovery - 1

May 11, 2015 updated by: Inflexxion, Inc.

Tobacco Cessation Clinical Field Study for Adults in Alcohol Abuse Recovery

The project's aim is to provide a targeted, computer-administered intervention to facilitate tobacco cessation for clients in alcohol treatment. The main focus of "On the Air: A tobacco cessation program for adults in alcohol recovery" is to reduce tobacco use of clients in alcohol treatment. The program will be offered through inpatient, residential, and outpatient treatment programs to help those struggling with alcohol addiction to understand, reduce, and stop tobacco use. Clients will develop a personalized tobacco cessation plan relevant to their readiness to quit tobacco use. Based on the metaphor of a television network, this tobacco cessation program contains information on personal risks, peer stories, cravings and withdrawal, a variety of interactive activities and tools, and also motivational feedback and tips to assist in the quitting process. Phase I was a proof of concept phase, in which we delivered a prototype CD-ROM on tobacco cessation. Phase II will involve completing the development of a functional CD-ROM tool which will be subjected to a clinical field trial with a group of adults (n=196) in treatment facilities for alcohol recovery. The clinical field study will involve finalizing the content, interface, and interactive features of the CD-ROM. We will also gather satisfaction data from both clients and counselors in the various treatment facilities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Puente, California, United States
        • SPIRITT Family Services
    • Massachusetts
      • Athol, Massachusetts, United States, 01331
        • Athol Behavioral Health Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Home of New Vision
      • Detroit, Michigan, United States
        • New Life Home for Recovering Women, Inc
    • New York
      • Brooklyn, New York, United States
        • Brooklyn Psychiatric Centers
      • New York, New York, United States
        • North General Hospital
    • Vermont
      • Montpelier, Vermont, United States
        • Maple Leaf Counseling, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Carry a primary DSM-IV diagnosis of alcohol abuse or dependence
  • Smoke at least one cigarette a day
  • Be willing to sign informed consent and undergo initial assessment and follow-up
  • Be willing to provide at least one collateral contact and collateral contact information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Smoking Cessation
Substance Abuse
Smoking Behavior

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inflexxion, Inc.

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Stephen F Butler, Ph.D., Inflexxion, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

April 27, 2005

First Submitted That Met QC Criteria

April 27, 2005

First Posted (Estimate)

April 28, 2005

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-80460-1
  • R44DA080460 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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  • Rutgers, The State University of New Jersey
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