SmokingNCT01383278
Evaluation of a Computer-Delivered 5 A's Intervention for Smoking
A study testing Computer-directed 5 A's intervention for smoking and Screening and resource provision in people with Smoking, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single session, computer-directed 5 A's intervention for smoking (experimental condition) to screening and resource provision (control condition). Follow-up visits will occur at 1 and 3 months post study enrollment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking
- What is being tested?
- Computer-directed 5 A's intervention for smoking and Screening and resource provision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 65 years
- Primary care patient
- Smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week
- Smoked at least 100 cigarettes (lifetime)
- Had no recent (past 90 days) use of other forms of tobacco (pipes, cigars, NRT)
- Able to speak English
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single session, computer-directed 5 A's intervention for smoking (experimental condition) to screening and resource provision (control condition). Follow-up visits will occur at 1 and 3 months post study enrollment. Measures will focus on tobacco use and related psychosocial outcomes (e.g. mood, stress). We will compare resources used and economic costs needed to implement each intervention.
The Investigators hypothesize that patients receiving the computer-directed intervention will have significantly higher tobacco abstinence rates at 3 months post study enrollment compared to the control group. If indeed the computerized intervention increases tobacco abstinence rates compared to the control group, this intervention could be used to increase access to treatment for the millions of US smokers, ultimately reducing tobacco mortality and morbidity rates in this country.
- Conditions
- Smoking
- Being tested
- Computer-directed 5 A's intervention for smoking, Screening and resource provision
- Keywords
- tobacco, smoking, smoking cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-directed 5 A's intervention for smokingBehavioural
Computer-directed 5 A's intervention for smoking
Screening and resource provisionBehavioural
Screening and resource provision
| Study group | Role | What they receive |
|---|---|---|
| Computer-directed 5 A's intervention for smoking | Experimental | Not described Receives: Behavioral: Computer-directed 5 A's intervention for smoking |
| Screening and resource provision | Active comparator | Not described Receives: Behavioral: Screening and resource provision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco use
The primary outcome variable for this study will be smoking cessation at 3 month follow-up as measured by self-report, salivary cotinine and carbon monoxide levels.
Measured: 3 months post-randomization
Secondary outcomes (2)
Mood and stress
By using the K-10 Instrument
Measured: 3 months post-randomization
Resource utilization and economic costs
Measured: 3 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionDec 2012
Why it stopped: Insufficient sample size to complete study and merged with parent grant funded study
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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dace Svikis, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383278
- Sponsor's protocol ID
- SBIRTCSVCU
- Other IDs
- R01DA026091
- Status last verified
- Dec 2015
- First submitted
- 24 Jun 2011
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Computer-Delivered 5 A's Intervention for Smoking
- ClinicalTrials.gov ID
- NCT01383278
- Acronym / sponsor ID
- SBIRTCSVCU
- Conditions
- Smoking
- Keywords
- tobacco, smoking, smoking cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient sample size to complete study and merged with parent grant funded study
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jun 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.
This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single session, computer-directed 5 A's intervention for smoking (experimental condition) to screening and resource provision (control condition). Follow-up visits will occur at 1 and 3 months post study enrollment. Measures will focus on tobacco use and related psychosocial outcomes (e.g. mood, stress). We will compare resources used and economic costs needed to implement each intervention.
The Investigators hypothesize that patients receiving the computer-directed intervention will have significantly higher tobacco abstinence rates at 3 months post study enrollment compared to the control group. If indeed the computerized intervention increases tobacco abstinence rates compared to the control group, this intervention could be used to increase access to treatment for the millions of US smokers, ultimately reducing tobacco mortality and morbidity rates in this country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-directed 5 A's intervention for smoking | Experimental | Behavioral: Computer-directed 5 A's intervention for smoking |
| Screening and resource provision | Active comparator | Behavioral: Screening and resource provision |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 - 65 years
- Primary care patient
- Smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week
- Smoked at least 100 cigarettes (lifetime)
- Had no recent (past 90 days) use of other forms of tobacco (pipes, cigars, NRT)
Key exclusion criteria (1 listed)
- Pregnant
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 |
|---|---|---|
| Computer-directed 5 A's intervention for smokingComputer-directed 5 A's intervention for smoking | Behavioural | Computer-directed 5 A's intervention for smoking |
| Screening and resource provisionScreening and resource provision | Behavioural | Screening and resource provision |
Primary outcome
Tobacco use
Time frame: 3 months post-randomization
The primary outcome variable for this study will be smoking cessation at 3 month follow-up as measured by self-report, salivary cotinine and carbon monoxide levels.
2 secondary outcomes
Mood and stress
Time frame: 3 months post-randomization
Resource utilization and economic costs
Time frame: 3 months post-randomization
Results and safety
The study was stopped early (reason given: Insufficient sample size to complete study and merged with parent grant funded study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 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.
Dace Svikis, 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 Computer-directed 5 A's intervention for smoking and Screening and resource provision 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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Dec 2015. 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 was stopped early (reason given: Insufficient sample size to complete study and merged with parent grant funded study). Results are not available in the source record.
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?
Tobacco use (time frame: 3 months post-randomization). 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 21 Dec 2015.