- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325727
Brief Computerized Feedback for Smokers in Recovery
November 13, 2012 updated by: Virginia Commonwealth University
The purpose of this research study is to find out more about smokers in recovery from addiction to alcohol/other drugs, and to evaluate a brief computerized smoking behavior feedback session.
The hypothesis is that a brief computerized smoking behavior feedback session will motivate more smokers to quit smoking than a control condition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
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
-
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Virginia
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Midlothian, Virginia, United States, 23225
- Substance Abuse Addiction and Recovery Alliance Center
-
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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:
- Be 18 years of age or older
- Be in recovery from addiction to alcohol and/or drugs (self-defined)
- Have smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week
- Have smoked at least 100 cigarettes (lifetime)
- Have an expired air carbon monoxide (CO) level of > 6 ppm (verifies current smoking)
- Be cognitively able to understand the proposed research design (screening followed by random assignment to one of the two conditions, if appropriate)
To be eligible to receive NRT (if chosen by the participant), participants must:
- Not be pregnant, breastfeeding, or plan to become pregnant in the next year
- Not have experienced a myocardial infarction (heart attack) or have been hospitalized for a heart-related problem in the last 2 weeks
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief computerized feedback
|
Brief computerized feedback
|
Active Comparator: Resources only
|
Participants randomized to the control group will discuss the option of quitting smoking, along with an information sheet, highlighting resources available to assist participants with smoking cessation, such as the Virginia Quitline (1-800 QUIT NOW) and nicotine replacement therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
% quit smoking
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2011
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
March 28, 2011
First Submitted That Met QC Criteria
March 29, 2011
First Posted (Estimate)
March 30, 2011
Study Record Updates
Last Update Posted (Estimate)
November 15, 2012
Last Update Submitted That Met QC Criteria
November 13, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- HM13510
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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