Cigarette SmokingPhase 2NCT02683161
Pre to Postoperative Smoking Cessation
A Phase 2 study testing Varenicline, Contingency Management and Behavioral Counseling in people with Cigarette Smoking and Obesity, run by Johns Hopkins University at 1 site in United States.
Trial summary
The study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention into a hospital setting, and assess measures of postsurgical recovery as a function of smoking cessation status. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cigarette Smoking, Obesity
- What is being tested?
- Varenicline, Contingency Management and Behavioral Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoker who has surgery scheduled 5-10 weeks in advance
Who cannot join
- being contraindicated for varenicline use
- evidence of psychiatric instability
- being unwilling/unable to adhere to the study schedule
- be unwilling to provide study access to medical records
- being otherwise judged by the study team to be inappropriate for study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
The study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention into a hospital setting, and assess measures of postsurgical recovery as a function of smoking cessation status.
Read the detailed description
This study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention (i.e., varenicline + monetary incentives + brief counseling) into a hospital setting by recruiting elective bariatric surgery patients and assessing theoretically relevant baseline characteristics (e.g., factors influencing smoking decisions, such as smoking motivation, delayed discounting, and distress tolerance) that may predict smoking cessation and post-surgical recovery outcomes. Participants will be required to attend a screening visit at the Behavioral Pharmacology Research Unit (BPRU) located on the Johns Hopkins Bayview Medical Campus, during which the participants will answer questionnaires, complete computerized tasks, and undergo sensory testing. Participants will then attend approximately 6 weekly study visits leading up to their bariatric surgery, and approximately 6 more weekly study visits after the surgery, as well as a 30-day follow-up visit, all located at the BPRU at Johns Hopkins Bayview. During the 6 pre-surgery visits and 6 post-surgery visits, participants will undergo an intensive smoking cessation treatment that includes administration of a medication called varenicline that has been FDA-approved for smoking cessation, as well as behavioral counseling sessions and monetary incentives for remaining smoke-free. After completing all study visits, participants will be asked to return for a 30-day follow-up visit, during which they will complete several study measures once more. Throughout the study, participants will be asked to periodically complete questionnaires, computerized tasks, and sensory testing. Investigators will also track outcomes associated with post-surgical recovery, including duration of hospital stay, hospital readmission, post-surgical complications, and prescription pain-killer use post-surgery.
- Conditions
- Cigarette Smoking, Obesity
- Being tested
- Varenicline, Contingency Management, Behavioral Counseling
- Medical subject headings
- Cigarette Smoking, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
Varenicline will be administered as clinically indicated and will begin approximately 4-6 weeks prior to surgery. All participants will receive a 1-week dose induction period before transitioning to a full maintenance dose.
Contingency ManagementBehavioural
Also called monetary incentives
Contingency Management payments will begin on the target quit date (week 2) and will be in place for 5 weeks or until surgery (whichever is sooner). Participants will receive monetary incentives for biochemical evidence of smoking abstinence.
Behavioral CounselingBehavioural
All participants will complete a 3-session behavioral counseling intervention with a trained member of our study staff during 3 of the pre-surgical study visits. This brief counseling intervention provides participants with information about the experience of quitting smoking, including a benefits/disadvantage analysis, functional analysis of craving/risk periods, and skills-building exercises to prevent lapse and relapse.
| Study group | Role | What they receive |
|---|---|---|
| Open-label trial | Other | All participants will attend approximately 6 study sessions pre-surgery and approximately 6 study sessions post-surgery, during which they will be provided three intervention components aimed at smoking cessation: a medication (varenicline) that has been FDA approved for smoking cessation, contingency management for biological evidence of nonsmoking, and behavioral counseling. Receives: Drug: Varenicline; Behavioral: Contingency Management; Behavioral: Behavioral Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Smoking Status
Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week
Measured: Assessed starting in week 2 of 12 weekly study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Inability to adequately recruit participants during pre-post operative period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly E Dunn, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683161
- Sponsor's protocol ID
- IRB00071969
- Status last verified
- Jun 2018
- First submitted
- 15 Oct 2015
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: The study was ended prematurely due to lack of recruitment. Data analysis is not possible and will not be reported.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre to Postoperative Smoking Cessation
- ClinicalTrials.gov ID
- NCT02683161
- Acronym / sponsor ID
- IRB00071969
- Conditions
- Cigarette Smoking, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to adequately recruit participants during pre-post operative period.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 20 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention into a hospital setting, and assess measures of postsurgical recovery as a function of smoking cessation status.
Detailed description
This study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention (i.e., varenicline + monetary incentives + brief counseling) into a hospital setting by recruiting elective bariatric surgery patients and assessing theoretically relevant baseline characteristics (e.g., factors influencing smoking decisions, such as smoking motivation, delayed discounting, and distress tolerance) that may predict smoking cessation and post-surgical recovery outcomes. Participants will be required to attend a screening visit at the Behavioral Pharmacology Research Unit (BPRU) located on the Johns Hopkins Bayview Medical Campus, during which the participants will answer questionnaires, complete computerized tasks, and undergo sensory testing. Participants will then attend approximately 6 weekly study visits leading up to their bariatric surgery, and approximately 6 more weekly study visits after the surgery, as well as a 30-day follow-up visit, all located at the BPRU at Johns Hopkins Bayview. During the 6 pre-surgery visits and 6 post-surgery visits, participants will undergo an intensive smoking cessation treatment that includes administration of a medication called varenicline that has been FDA-approved for smoking cessation, as well as behavioral counseling sessions and monetary incentives for remaining smoke-free. After completing all study visits, participants will be asked to return for a 30-day follow-up visit, during which they will complete several study measures once more. Throughout the study, participants will be asked to periodically complete questionnaires, computerized tasks, and sensory testing. Investigators will also track outcomes associated with post-surgical recovery, including duration of hospital stay, hospital readmission, post-surgical complications, and prescription pain-killer use post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label trial | Other | Drug: Varenicline, Behavioral: Contingency Management, Behavioral: Behavioral CounselingAll participants will attend approximately 6 study sessions pre-surgery and approximately 6 study sessions post-surgery, during which they will be provided three intervention components aimed at smoking cessation: a medication (varenicline) that has been FDA approved for smoking cessation, contingency management for biological evidence of nonsmoking, and behavioral counseling. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smoker who has surgery scheduled 5-10 weeks in advance
Key exclusion criteria (5 listed)
- being contraindicated for varenicline use
- evidence of psychiatric instability
- being unwilling/unable to adhere to the study schedule
- be unwilling to provide study access to medical records
- being otherwise judged by the study team to be inappropriate for study participation
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 |
|---|---|---|
| VareniclineAlso: ChantixVarenicline will be administered as clinically indicated and will begin approximately 4-6 weeks prior to surgery. All participants will receive a 1-week dose induction period before transitioning to a full maintenance dose. | Drug | Open-label trial |
| Contingency ManagementAlso: monetary incentivesContingency Management payments will begin on the target quit date (week 2) and will be in place for 5 weeks or until surgery (whichever is sooner). Participants will receive monetary incentives for biochemical evidence of smoking abstinence. | Behavioural | Open-label trial |
| Behavioral CounselingAll participants will complete a 3-session behavioral counseling intervention with a trained member of our study staff during 3 of the pre-surgical study visits. This brief counseling intervention provides participants with information about the experience of quitting smoking, including a benefits/disadvantage analysis, functional analysis of craving/risk periods, and skills-building exercises to prevent lapse and relapse. | Behavioural | Open-label trial |
Primary outcome
Change in Smoking Status
Time frame: Assessed starting in week 2 of 12 weekly study visits
Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The study was ended prematurely due to lack of recruitment. Data analysis is not possible and will not be reported.
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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.
Kelly E Dunn, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varenicline, Contingency Management and Behavioral Counseling in people with Cigarette Smoking and Obesity, run by Johns Hopkins 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 1 inclusion and 5 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 17 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Smoking Status (time frame: Assessed starting in week 2 of 12 weekly study visits). 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 17 Jul 2018.