SmokingNCT01325727
Brief Computerized Feedback for Smokers in Recovery
A study testing Brief computerized feedback in people with Smoking, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Brief computerized feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Nov 2012
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Abuse Addiction and Recovery Alliance Center
Midlothian, Virginia, 23225
About this study
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.
- Conditions
- Smoking
- Being tested
- Brief computerized feedback, Resources only (control)
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief computerized feedbackOther
Brief computerized feedback
Resources only (control)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief computerized feedback | Experimental | Brief computerized feedback Receives: Other: Brief computerized feedback |
| Resources only | Active comparator | Not described Receives: Other: Resources only (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% quit smoking
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Breland, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325727
- Sponsor's protocol ID
- HM13510
- Status last verified
- Nov 2012
- First submitted
- 28 Mar 2011
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Computerized Feedback for Smokers in Recovery
- ClinicalTrials.gov ID
- NCT01325727
- Acronym / sponsor ID
- HM13510
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Mar 2011 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief computerized feedback | Experimental | Other: Brief computerized feedbackBrief computerized feedback |
| Resources only | Active comparator | Other: Resources only (control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Brief computerized feedbackBrief computerized feedback | Other | Brief computerized feedback |
| Resources only (control)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. | Other | Resources only |
Primary outcome
% quit smoking
Time frame: 4 weeks
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 15 Nov 2012.
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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.
Alison Breland, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief computerized feedback in people with Smoking, run by Virginia Commonwealth University at 1 site 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 9 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 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
% quit smoking (time frame: 4 weeks). 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 15 Nov 2012.