Pre to Postoperative Smoking Cessation



Status:Terminated
Conditions:Obesity Weight Loss, Smoking Cessation
Therapuetic Areas:Endocrinology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 100
Updated:7/19/2018
Start Date:October 2015
End Date:July 2017

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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.

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.

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
We found this trial at
1
site
4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Phone: 410-550-2254
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