NCT00109460

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

7 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

Study Start

First participant enrolled

March 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2005

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

April 27, 2005

Last Update Submit

May 11, 2015

Conditions

Keywords

Tobacco

Outcome Measures

Primary Outcomes (3)

  • Smoking Behavior

  • Smoking Cessation

  • Substance Abuse

Interventions

Eligibility Criteria

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

SPIRITT Family Services

La Puente, California, United States

Location

Athol Behavioral Health Center

Athol, Massachusetts, 01331, United States

Location

Home of New Vision

Ann Arbor, Michigan, 48104, United States

Location

New Life Home for Recovering Women, Inc

Detroit, Michigan, United States

Location

Brooklyn Psychiatric Centers

Brooklyn, New York, United States

Location

North General Hospital

New York, New York, United States

Location

Maple Leaf Counseling, Inc.

Montpelier, Vermont, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Stephen F Butler, Ph.D.

    Inflexxion, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
SINGLE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2005

First Posted

April 28, 2005

Study Start

March 1, 2003

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations