Tobacco Cessation Field Study for Adults in Recovery - 1

Tobacco Use Disorder Clinical Trial

Official title:

Tobacco Cessation Clinical Field Study for Adults in Alcohol Abuse Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109460
• Other study ID #: NIDA-80460-1
• Secondary ID: R44DA080460
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2005
• Last updated: May 11, 2015
• Start date: March 2003
• Est. completion date: March 2005

Study information

• Verified date: May 2015
• Source: Inflexxion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Crossover Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Tobacco Use Disorder

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Inflexxion, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Behavior
Primary	Smoking Cessation
Primary	Substance Abuse