Tobacco Cessation Field Study for Adults in Recovery - 1

• Sponsor: Inflexxion, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00109460
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 203
• Locations: 7
• Duration (Months): 24
• Patients Per Site: 29
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder	Behavioral: Tobacco Use Disorder	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 203 participants
• Intervention Model: Crossover Assignment
• Masking: Single
• Official Title: Tobacco Cessation Clinical Field Study for Adults in Alcohol Abuse Recovery
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Mar 1, 2005
• Actual Study Completion Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. Smoking Behavior []

2. Smoking Cessation []

3. Substance Abuse []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SPIRITT Family Services	La Puente	California	United States
2	Athol Behavioral Health Center	Athol	Massachusetts	United States	01331
3	Home of New Vision	Ann Arbor	Michigan	United States	48104
4	New Life Home for Recovering Women, Inc	Detroit	Michigan	United States
5	Brooklyn Psychiatric Centers	Brooklyn	New York	United States
6	North General Hospital	New York	New York	United States
7	Maple Leaf Counseling, Inc.	Montpelier	Vermont	United States

Sponsors and Collaborators

• Inflexxion, Inc.
• National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Inflexxion, Inc.
• ClinicalTrials.gov Identifier: NCT00109460
• Other Study ID Numbers: NIDA-80460-1; R44DA080460
• First Posted: Apr 28, 2005
• Last Update Posted: May 13, 2015
• Last Verified: May 1, 2015

• Keywords provided by Inflexxion, Inc.: Tobacco
• Additional relevant MeSH terms: Tobacco Use Disorder

Study Results

No Results Posted as of May 13, 2015