Cigarette Smoking, Obesity
Conditions
Brief 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.
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.
Interventions
DRUGVarenicline
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.
BEHAVIORALContingency Management
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.
BEHAVIORALBehavioral Counseling
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.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Smoker who has surgery scheduled 5-10 weeks in advance
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Smoking Status | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open-label Trial Open label trial of varenicline, administered as clinically indicated, for smoking cessation in patients prior to and after surgery. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Open-label Trial |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in Smoking Status
Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week
Time frame: Assessed starting in week 2 of 12 weekly study visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open-label Group | Change in Smoking Status | Week 2 | 7.4 Mean cigarettes per/day | Standard Deviation 4.1 |
| Open-label Group | Change in Smoking Status | Week 3 | 5.9 Mean cigarettes per/day | Standard Deviation 2.3 |
| Open-label Group | Change in Smoking Status | Week 4 | 6.0 Mean cigarettes per/day | Standard Deviation 2.1 |
| Open-label Group | Change in Smoking Status | Week 5 | 4.9 Mean cigarettes per/day | Standard Deviation 1.3 |
| Open-label Group | Change in Smoking Status | Week 6 | 0.8 Mean cigarettes per/day | Standard Deviation 0.7 |
| Open-label Group | Change in Smoking Status | Week 7 | 0 Mean cigarettes per/day | Standard Deviation 0 |
| Open-label Group | Change in Smoking Status | Week 8 | 0 Mean cigarettes per/day | Standard Deviation 0 |
| Open-label Group | Change in Smoking Status | Week 9 | 0 Mean cigarettes per/day | Standard Deviation 0 |
| Open-label Group | Change in Smoking Status | Week 11 | 0 Mean cigarettes per/day | Standard Deviation 0 |
| Open-label Group | Change in Smoking Status | Week 12 | 0 Mean cigarettes per/day | Standard Deviation 0 |
| Open-label Group | Change in Smoking Status | Week 10 | 0.3 Mean cigarettes per/day | Standard Deviation 0.6 |