Cigarette SmokingDonaghueNCT00683280
Contingency Management and Pharmacotherapy for Smoking Cessation
A study testing contingency management in people with Cigarette Smoking, run by UConn Health at 1 site in United States.
Trial summary
In total, 70 smokers will be randomized to: standard of care smoking cessation medication varenicline alone (an FDA-approved smoking cessation medication) or varenicline plus contingency management (CM) (a behavioral procedure with rewards for target behaviors, like smoking abstinence). 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?
- contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Aug 2010
- 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
- smoke >10 cigarettes/day, with no abstinent period exceeding 3 months in past year
- expired CO of >8 ppm
- self-reported desire to stop smoking
- >18 years of age
- resting systolic BP<160 mmHg and diastolic BP<100 mmHg and otherwise in good health
- if on antihypertensive medication, have not changed medications in the past month and do not intend to change in next 3 months
- English speaking
Who cannot join
- receipt of smoking cessation treatment (behavioral or pharmacological) in past month
- serious or unstable medical disease in past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
- evidence or history of allergic reactions contraindicating varenicline or clinically significant laboratory or electrocardiographic (ECG) abnormalities
- breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential
- arm circumference of >42 cm
- serious psychiatric illness in past 6 months (e.g., schizophrenia, psychosis, suicide risk, drug or alcohol dependence other than nicotine)
Show all 9Show fewer
- use of tobacco containing products other than cigarettes in past month and do not agree to abstain from use of these products during study participation
- ongoing use of any of the following medications: nicotine replacement therapies, monoamine oxidase inhibitors, antipsychotics, mood stabilizers, or naltrexone
- in recovery for pathological gambling, due to potential similarity with prize CM, although no increases in gambling have been noted
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030-3944
About this study
In total, 70 smokers will be randomized to: standard of care smoking cessation medication varenicline alone (an FDA-approved smoking cessation medication) or varenicline plus contingency management (CM) (a behavioral procedure with rewards for target behaviors, like smoking abstinence). Patients in both conditions will receive varenicline for 12 weeks with standard smoking cessation therapy and regular breath and urine sample monitoring for smoking. Patients assigned to CM will earn chances to win prizes for each breath sample that tests negative for smoking, and urine samples that test negative for smoking will result in even greater chances for prizes. More CM patients are expected to achieve and maintain abstinence than patients receiving varenicline alone.
- Conditions
- Cigarette Smoking
- Being tested
- contingency management, Standard of Care
- Keywords
- Contingency Management, Cigarette Smoking Cessation, varenicline
- Medical subject headings
- Cigarette Smoking, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contingency managementBehavioural
Prize-based contingency management, with the opportunity to earn prizes for expired carbon monoxide levels reading 6ppm or less and urinary cotinine levels reading 30ng/ml or less for 4 weeks.
Standard of CareOther
varenicline (smoking cessation medication) 0.5mg po daily Days 1-3, 0.5mg po twice daily Days 4-7, 1.0 mg po twice daily Days 8-84.
Standard of CareOther
Twice weekly brief counseling based on public health service guidelines for quitting smoking.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Medication (varenicline) for 12 weeks (Day 1 through 84) and brief counseling based on public health service guidelines for 5 weeks (Day 1 through 35). Receives: Other: Standard of Care |
| Standard of Care plus Contingency Management | Experimental | Medication (varenicline) for 12 weeks (Day 1 through 84), brief counseling based on public health service guidelines for 5 weeks (Day 1 through 35), plus prize-based contingency management for carbon monoxide samples and urinary cotinine samples that meet smoking abstinence criteria. Receives: Behavioral: contingency management; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests and self-report.
Measured: weeks 5, 12 & 24
Secondary outcomes (1)
Changes from baseline in ambulatory 24-hour systolic blood pressure.
Measured: 6 and 24 weeks following the initiation of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2010
- Study completionAug 2010
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
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Responsible party
- Sponsor
- Investigators
- Sheila M Alessi, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683280
- Sponsor's protocol ID
- 08-035-3
- Other IDs
- DF 07-028
- Acronym
- Donaghue
- Status last verified
- Jan 2018
- First submitted
- 14 May 2008
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management and Pharmacotherapy for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00683280
- Acronym / sponsor ID
- Donaghue / 08-035-3
- Conditions
- Cigarette Smoking
- Keywords
- Contingency Management, Cigarette Smoking Cessation, varenicline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Study start
- May 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 May 2008 (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.
In total, 70 smokers will be randomized to: standard of care smoking cessation medication varenicline alone (an FDA-approved smoking cessation medication) or varenicline plus contingency management (CM) (a behavioral procedure with rewards for target behaviors, like smoking abstinence). Patients in both conditions will receive varenicline for 12 weeks with standard smoking cessation therapy and regular breath and urine sample monitoring for smoking. Patients assigned to CM will earn chances to win prizes for each breath sample that tests negative for smoking, and urine samples that test negative for smoking will result in even greater chances for prizes. More CM patients are expected to achieve and maintain abstinence than patients receiving varenicline alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareMedication (varenicline) for 12 weeks (Day 1 through 84) and brief counseling based on public health service guidelines for 5 weeks (Day 1 through 35). |
| Standard of Care plus Contingency Management | Experimental | Behavioral: contingency management, Other: Standard of CareMedication (varenicline) for 12 weeks (Day 1 through 84), brief counseling based on public health service guidelines for 5 weeks (Day 1 through 35), plus prize-based contingency management for carbon monoxide samples and urinary cotinine samples that meet smoking abstinence criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- smoke >10 cigarettes/day, with no abstinent period exceeding 3 months in past year
- expired CO of >8 ppm
- self-reported desire to stop smoking
- >18 years of age
- resting systolic BP<160 mmHg and diastolic BP<100 mmHg and otherwise in good health
Key exclusion criteria (9 listed)
- receipt of smoking cessation treatment (behavioral or pharmacological) in past month
- serious or unstable medical disease in past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
- evidence or history of allergic reactions contraindicating varenicline or clinically significant laboratory or electrocardiographic (ECG) abnormalities
- breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential
- arm circumference of >42 cm
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 |
|---|---|---|
| contingency managementPrize-based contingency management, with the opportunity to earn prizes for expired carbon monoxide levels reading 6ppm or less and urinary cotinine levels reading 30ng/ml or less for 4 weeks. | Behavioural | Standard of Care plus Contingency Management |
| Standard of Carevarenicline (smoking cessation medication) 0.5mg po daily Days 1-3, 0.5mg po twice daily Days 4-7, 1.0 mg po twice daily Days 8-84. | Other | Standard of Care, Standard of Care plus Contingency Management |
| Standard of CareTwice weekly brief counseling based on public health service guidelines for quitting smoking. | Other | Standard of Care, Standard of Care plus Contingency Management |
Primary outcome
Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests and self-report.
Time frame: weeks 5, 12 & 24
1 secondary outcome
Changes from baseline in ambulatory 24-hour systolic blood pressure.
Time frame: 6 and 24 weeks following the initiation of medication
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 16 Jan 2018.
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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.
Sheila M Alessi, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contingency management in people with Cigarette Smoking, run by UConn Health 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 7 inclusion and 9 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 16 Jan 2018. 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?
Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests and self-report. (time frame: weeks 5, 12 & 24). 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 16 Jan 2018.