Cigarette SmokingNCT01181661
Internet-based Group Contingency Management to Promote Smoking Abstinence
A study testing Full Group Contingency and Mixed Group Contingency in people with Cigarette Smoking, run by National Development and Research Institutes, Inc. at 2 sites in United States.
Trial summary
The purpose of the study is to develop and test an Internet-based group contingency management program designed to promote smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Full Group Contingency and Mixed Group Contingency
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Aug 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- self-reported smoker
- ability to use the Internet
- permission to contact applicant by phone
Who cannot join
- self-report of a history of or current severe or unstable medical or psychiatric illness that would interfere with the study
- inability to avoid high levels of ambient CO (e.g., occupational exposure; lives with a another smoker who smokes in the home)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32611
National Development and Research Institutes
New York, New York, 10010
About this study
The purpose of the study is to develop and test an Internet-based group contingency management program designed to promote smoking cessation.
- Conditions
- Cigarette Smoking
- Being tested
- Full Group Contingency, Mixed Group Contingency
- Keywords
- Cigarette, Smoking, Nicotine, Contingency Management, Voucher Reinforcement, Smoking Abstinence, Internet, Internet-based Treatment, Group Contingencies
- 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.
Full Group ContingencyBehavioural
This group (n = 20) will earn vouchers based only on team (n = 4) performance. Only if all members of the team submit a negative sample (CO ≤ 4 ppm), will they each earn a voucher.
Mixed Group ContingencyBehavioural
This group (n = 20) will earn vouchers based on both individual and team (n = 4) performance. If an individual submits a negative sample (CO ≤ 4 ppm), s/he will earn a voucher. Additionally, bonus vouchers will be earned if all team members submit negative samples.
| Study group | Role | What they receive |
|---|---|---|
| Full Group Contingency | Experimental | This group (n = 20) will earn vouchers based only on team (n = 4) performance. Only if all members of the team submit a negative sample (CO ≤ 4 ppm), will they each earn a voucher. Receives: Behavioral: Full Group Contingency |
| Mixed Group Contingency | Experimental | This group (n = 20) will earn vouchers based on both individual and team (n = 4) performance. If an individual submits a negative sample (CO ≤ 4 ppm), s/he will earn a voucher. Additionally, bonus vouchers will be earned if all team members submit negative samples. Receives: Behavioral: Mixed Group Contingency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath CO
Twice daily breath CO samples obtained during baseline and treatment
Measured: 8 weeks
Secondary outcomes (3)
Point prevalence measure of abstinence
Abstinence will be defined as: (a) CO sample ≤ 4 ppm; (b) cotinine < 50 ng/ml; and (c) reporting not smoking, not even a puff in the last 7 days.
Measured: at the end of treatment (approximately week 4) and at 3 month follow-up
Duration of abstinence during treatment.
The longest duration of sustained abstinence (CO ≤ 4 ppm) based on the twice-daily breath samples during the treatment period.
Measured: 3 weeks
Rate of social exchanges
The number of comments posted on the discussion forum during treatment.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionAug 2013
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
- 40 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
- NCT01181661
- Sponsor's protocol ID
- 1R21DA029162
- Other IDs
- 1R21DA029162
- Status last verified
- Sep 2014
- First submitted
- 12 Aug 2010
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Group Contingency Management to Promote Smoking Abstinence
- ClinicalTrials.gov ID
- NCT01181661
- Acronym / sponsor ID
- 1R21DA029162
- Conditions
- Cigarette Smoking
- Keywords
- Cigarette, Smoking, Nicotine, Contingency Management, Voucher Reinforcement, Smoking Abstinence, Internet, Internet-based Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Aug 2010 (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 develop and test an Internet-based group contingency management program designed to promote smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Group Contingency | Experimental | Behavioral: Full Group ContingencyThis group (n = 20) will earn vouchers based only on team (n = 4) performance. Only if all members of the team submit a negative sample (CO ≤ 4 ppm), will they each earn a voucher. |
| Mixed Group Contingency | Experimental | Behavioral: Mixed Group ContingencyThis group (n = 20) will earn vouchers based on both individual and team (n = 4) performance. If an individual submits a negative sample (CO ≤ 4 ppm), s/he will earn a voucher. Additionally, bonus vouchers will be earned if all team members submit negative samples. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- self-reported smoker
- ability to use the Internet
- permission to contact applicant by phone
Key exclusion criteria (2 listed)
- self-report of a history of or current severe or unstable medical or psychiatric illness that would interfere with the study
- inability to avoid high levels of ambient CO (e.g., occupational exposure; lives with a another smoker who smokes in the home)
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 |
|---|---|---|
| Full Group ContingencyThis group (n = 20) will earn vouchers based only on team (n = 4) performance. Only if all members of the team submit a negative sample (CO ≤ 4 ppm), will they each earn a voucher. | Behavioural | Full Group Contingency |
| Mixed Group ContingencyThis group (n = 20) will earn vouchers based on both individual and team (n = 4) performance. If an individual submits a negative sample (CO ≤ 4 ppm), s/he will earn a voucher. Additionally, bonus vouchers will be earned if all team members submit negative samples. | Behavioural | Mixed Group Contingency |
Primary outcome
Breath CO
Time frame: 8 weeks
Twice daily breath CO samples obtained during baseline and treatment
3 secondary outcomes
Point prevalence measure of abstinence
Time frame: at the end of treatment (approximately week 4) and at 3 month follow-up
Duration of abstinence during treatment.
Time frame: 3 weeks
Rate of social exchanges
Time frame: 3 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 25 Sep 2014.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Group Contingency and Mixed Group Contingency in people with Cigarette Smoking, run by National Development and Research Institutes, Inc. at 2 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 3 inclusion and 2 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 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Breath CO (time frame: 8 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 25 Sep 2014.