Tobacco Use DisorderPhase 2NCT00109460
Tobacco Cessation Field Study for Adults in Recovery - 1
A Phase 2 study testing Tobacco Use Disorder in people with Tobacco Use Disorder, run by Inflexxion, Inc. at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Tobacco Use Disorder
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 203 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2003to Mar 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Home of New Vision
Ann Arbor, Michigan, 48104
Athol Behavioral Health Center
Athol, Massachusetts, 01331
Brooklyn Psychiatric Centers
Brooklyn, New York
New Life Home for Recovering Women, Inc
Detroit, Michigan
SPIRITT Family Services
La Puente, California
Maple Leaf Counseling, Inc.
Montpelier, Vermont
North General Hospital
New York, New York
About this study
Official title: 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Tobacco Use Disorder
- Keywords
- Tobacco
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco Use DisorderBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Behavior
Smoking Cessation
Substance Abuse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2005 (estimated)
- Study startMar 2003
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflexxion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Stephen F Butler, Ph.D., Principal investigator, Inflexxion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109460
- Sponsor's protocol ID
- NIDA-80460-1
- Other IDs
- R44DA080460
- Status last verified
- May 2015
- First submitted
- 27 Apr 2005
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Cessation Clinical Field Study for Adults in Alcohol Abuse Recovery
- ClinicalTrials.gov ID
- NCT00109460
- Acronym / sponsor ID
- NIDA-80460-1
- Conditions
- Tobacco Use Disorder
- Keywords
- Tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Inflexxion, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 28 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco Use Disorder | Behavioural | – |
Primary outcome
Smoking Behavior
Smoking Cessation
Substance Abuse
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen F Butler, Ph.D. principal investigator
Inflexxion, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tobacco Use Disorder in people with Tobacco Use Disorder, run by Inflexxion, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Behavior. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.