Pre to Postoperative Smoking Cessation

Phase 2

Terminated

• Conditions: Cigarette Smoking; Obesity
• Interventions: Drug: Varenicline; Behavioral: Contingency Management; Behavioral: Behavioral Counseling

• Registration Number: NCT02683161
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-17
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Results First Submitted: 2018-04-19
• Results First Submitted QC: 2018-05-23
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-19
• Results First Posted: 2018-06-20
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label trial	Contingency Management	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.
Open-label trial	Behavioral Counseling	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.
Open-label trial	Varenicline	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States