Cigarette SmokingNCT00926939
Technological Innovations in Behavioral Treatments for Cigarette Smoking
A study testing Reinforcement for the abstinence of smoking and Reinforcement for submission of videos with CO sample in people with Cigarette Smoking, run by National Development and Research Institutes, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to evaluate a sustainable and broadly accessible treatment delivery model (Motiv8) for smoking cessation based on abstinence-reinforcement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Reinforcement for the abstinence of smoking and Reinforcement for submission of videos with CO sample
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported smoker
- Permission to contact applicant by phone
- Ability to use the internet
Who cannot join
- Self-report of a history of or current severe or unstable medical or psychiatric illness that would interfere with the study
Trial locations and contacts
1 site in 1 country.
United States1 site
National Development and Research Institutes
New York, New York, 10010
About this study
The purpose of the study is to evaluate a sustainable and broadly accessible treatment delivery model (Motiv8) for smoking cessation based on abstinence-reinforcement.
Read the detailed description
Smokers are randomly assigned to one of two groups: an Abstinence Contingent (AC) group and a Submission Contingent (SC) group. The AC group receives vouchers for abstaining from smoking (measured by a carbon monoxide monitor and confirmed through video-submission), and the SC group receives vouchers for submitting videos of their carbon monoxide breath tests. Both groups take videos of their CO-monitoring on a secure website designed for the study, as well as receive standard care counseling and education related to smoking cessation. The main intervention lasts four weeks, and a three-week maintenance phase will follow. Assessments will be conducted at intake, week four (end of the main treatment phase), and at three and six months after the intervention period is completed
- Conditions
- Cigarette Smoking
- Being tested
- Reinforcement for the abstinence of smoking, Reinforcement for submission of videos with CO sample
- Keywords
- Cigarette, Nicotine, Smoking, Contingency Management, Voucher reinforcement, Smoking Abstinence, Internet-based treatment
- Medical subject headings
- Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforcement for the abstinence of smokingBehavioural
Participants in this intervention group will receive vouchers contingent upon a CO sample of 4ppm or less.
Reinforcement for submission of videos with CO sampleBehavioural
This intervention group will receive vouchers contingent on their submission of videos of their CO breath tests.
| Study group | Role | What they receive |
|---|---|---|
| Abstinence Contingent (AC) | Experimental | This group will receive vouchers contingent on smoking reduction and smoking abstinence (confirmed through video submissions). Abstinence is defined as a CO sample of 4ppm or less. Receives: Behavioral: Reinforcement for the abstinence of smoking |
| Submission Contingent (SC) | Experimental | This group receives vouchers for submitting videos of their CO breath test. Receives: Behavioral: Reinforcement for submission of videos with CO sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
CO sample of ≤ 4ppm
Measured: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention
Participant reporting not smoking, not even a puff in the last 7 days.
Measured: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention
Secondary outcomes (2)
Twice-daily breath CO samples obtained during treatment period.
Measured: First 4 weeks of treatment
The longest duration of sustained abstinence based on the twice-daily breath samples during the treatment period.
Measured: First 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jesse Dallery, National Development and Research Institutes, Inc.
- Investigators
- Jesse Dallery, PhD, Principal investigator, National Development and Research Institutes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926939
- Sponsor's protocol ID
- R01DA023469
- Other IDs
- R01DA023469
- Status last verified
- Apr 2015
- First submitted
- 23 Jun 2009
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technological Innovations in Behavioral Treatments for Cigarette Smoking
- ClinicalTrials.gov ID
- NCT00926939
- Acronym / sponsor ID
- R01DA023469
- Conditions
- Cigarette Smoking
- Keywords
- Cigarette, Nicotine, Smoking, Contingency Management, Voucher reinforcement, Smoking Abstinence, Internet-based treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2009
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Jun 2009 (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 the study is to evaluate a sustainable and broadly accessible treatment delivery model (Motiv8) for smoking cessation based on abstinence-reinforcement.
Detailed description
Smokers are randomly assigned to one of two groups: an Abstinence Contingent (AC) group and a Submission Contingent (SC) group. The AC group receives vouchers for abstaining from smoking (measured by a carbon monoxide monitor and confirmed through video-submission), and the SC group receives vouchers for submitting videos of their carbon monoxide breath tests. Both groups take videos of their CO-monitoring on a secure website designed for the study, as well as receive standard care counseling and education related to smoking cessation. The main intervention lasts four weeks, and a three-week maintenance phase will follow. Assessments will be conducted at intake, week four (end of the main treatment phase), and at three and six months after the intervention period is completed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abstinence Contingent (AC) | Experimental | Behavioral: Reinforcement for the abstinence of smokingThis group will receive vouchers contingent on smoking reduction and smoking abstinence (confirmed through video submissions). Abstinence is defined as a CO sample of 4ppm or less. |
| Submission Contingent (SC) | Experimental | Behavioral: Reinforcement for submission of videos with CO sampleThis group receives vouchers for submitting videos of their CO breath test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-reported smoker
- Permission to contact applicant by phone
- Ability to use the internet
Key exclusion criteria (1 listed)
- Self-report of a history of or current severe or unstable medical or psychiatric illness that would interfere with the study
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 |
|---|---|---|
| Reinforcement for the abstinence of smokingParticipants in this intervention group will receive vouchers contingent upon a CO sample of 4ppm or less. | Behavioural | Abstinence Contingent (AC) |
| Reinforcement for submission of videos with CO sampleThis intervention group will receive vouchers contingent on their submission of videos of their CO breath tests. | Behavioural | Submission Contingent (SC) |
Primary outcome
CO sample of ≤ 4ppm
Time frame: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention
Participant reporting not smoking, not even a puff in the last 7 days.
Time frame: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention
2 secondary outcomes
Twice-daily breath CO samples obtained during treatment period.
Time frame: First 4 weeks of treatment
The longest duration of sustained abstinence based on the twice-daily breath samples during the treatment period.
Time frame: First 4 weeks of treatment
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 14 Apr 2015.
- Study websiteLink provided by the sponsor.
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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.
Jesse Dallery, PhD principal investigator
National Development and Research Institutes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinforcement for the abstinence of smoking and Reinforcement for submission of videos with CO sample in people with Cigarette Smoking, run by National Development and Research Institutes, Inc. 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 3 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: finished, as of the sponsor's last update on 14 Apr 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 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?
CO sample of ≤ 4ppm (time frame: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention). The study lists 2 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 14 Apr 2015.