Clinical trial NCT02683161: Pre to Postoperative Smoking Cessation
Official title: Pre to Postoperative Smoking Cessation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cigarette Smoking
Obesity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Smoking Status
timeFrame: Assessed starting in week 2 of 12 weekly study visits
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kelly E Dunn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: