Cigarette SmokingNCT01736982
Contingency Management for Smoking Cessation in the Homeless
A study testing Contingency Management in people with Cigarette Smoking, run by UConn Health at 1 site in United States.
Trial summary
Smoking cessation services are an unmet need among the homeless, who smoke at rates more than 3 times the national estimate; successful interventions in this underserved population have the potential for improving individual and public health. 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
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2016
- 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
- age ≥ 18 years
- homeless
- regular smoker
Who cannot join
- non-English speaking
- contra-indications for transdermal nicotine
- in recovery for pathological gambling
Trial locations and contacts
1 site in 1 country.
United States1 site
The Friendship Center
New Britain, Connecticut, 06051
About this study
Smoking cessation services are an unmet need among the homeless, who smoke at rates more than 3 times the national estimate; successful interventions in this underserved population have the potential for improving individual and public health. Contingency management (CM) is a behavioral intervention with efficacy in a number of substance use disorder populations, including smokers. However, no known studies have evaluated the effect of CM in homeless smokers. The investigators plan to examine smoking-related outcomes in homeless treatment-seeking smokers (N = 70) randomized to standard care smoking cessation (transdermal nicotine replacement therapy [NRT] + standard counseling + carbon monoxide [CO] monitoring) or standard care plus CM (NRT + standard counseling + CO monitoring + CM) conditions. Standard counseling and CO monitoring will occur for the first 4 weeks, with NRT use continuing through week 8. Participants in both conditions will meet with study staff up to twice daily on weekdays for biochemical verification of smoking status. Participants in the CM condition will have the opportunity to earn prizes for negative breath samples (CO ≤ 4 ppm) up to twice daily on weekdays. CO breath samples will be collected at all visits. The investigators expect that participants randomized to CM will have better outcomes compared to those in standard care.
- Conditions
- Cigarette Smoking
- Being tested
- Contingency Management, Standard of Care
- Keywords
- Cigarette Smoking, Homeless, Contingency Management, Smoking Cessation
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Participants earn reinforcement in the form of prizes for breath samples that test negative for cigarette smoking.
Standard of CareOther
Standard smoking cessation counseling
Standard of CareOther
transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)]
Standard of CareOther
Breath sample monitoring
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)], breath sample monitoring, standard smoking cessation counseling Receives: Other: Standard of Care |
| Standard of Care plus Contingency Management | Experimental | Standard smoking cessation intervention plus contingency management 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.
Longest Duration of Abstinence
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2016
- Study completionJul 2016
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Carla J Rash, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736982
- Sponsor's protocol ID
- 12-186-2
- Other IDs
- R21DA031897
- Status last verified
- Jan 2018
- First submitted
- 26 Nov 2012
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 for Smoking Cessation in the Homeless
- ClinicalTrials.gov ID
- NCT01736982
- Acronym / sponsor ID
- 12-186-2
- Conditions
- Cigarette Smoking
- Keywords
- Cigarette Smoking, Homeless, Contingency Management, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Nov 2012 (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.
Smoking cessation services are an unmet need among the homeless, who smoke at rates more than 3 times the national estimate; successful interventions in this underserved population have the potential for improving individual and public health. Contingency management (CM) is a behavioral intervention with efficacy in a number of substance use disorder populations, including smokers. However, no known studies have evaluated the effect of CM in homeless smokers. The investigators plan to examine smoking-related outcomes in homeless treatment-seeking smokers (N = 70) randomized to standard care smoking cessation (transdermal nicotine replacement therapy [NRT] + standard counseling + carbon monoxide [CO] monitoring) or standard care plus CM (NRT + standard counseling + CO monitoring + CM) conditions. Standard counseling and CO monitoring will occur for the first 4 weeks, with NRT use continuing through week 8. Participants in both conditions will meet with study staff up to twice daily on weekdays for biochemical verification of smoking status. Participants in the CM condition will have the opportunity to earn prizes for negative breath samples (CO ≤ 4 ppm) up to twice daily on weekdays. CO breath samples will be collected at all visits. The investigators expect that participants randomized to CM will have better outcomes compared to those in standard care.
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 Caretransdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)], breath sample monitoring, standard smoking cessation counseling |
| Standard of Care plus Contingency Management | Experimental | Behavioral: Contingency Management, Other: Standard of CareStandard smoking cessation intervention plus contingency management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- homeless
- regular smoker
Key exclusion criteria (3 listed)
- non-English speaking
- contra-indications for transdermal nicotine
- in recovery for pathological gambling
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 ManagementParticipants earn reinforcement in the form of prizes for breath samples that test negative for cigarette smoking. | Behavioural | Standard of Care plus Contingency Management |
| Standard of CareStandard smoking cessation counseling | Other | Standard of Care, Standard of Care plus Contingency Management |
| Standard of Caretransdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)] | Other | Standard of Care, Standard of Care plus Contingency Management |
| Standard of CareBreath sample monitoring | Other | Standard of Care, Standard of Care plus Contingency Management |
Primary outcome
Longest Duration of Abstinence
Time frame: Week 4
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.
Related trials for Cigarette Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking
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.
Carla J Rash, PhD 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 3 inclusion and 3 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?
Longest Duration of Abstinence (time frame: Week 4). 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.