Pre to Postoperative Smoking Cessation

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Cigarette Smoking
• Intervention / Treatment: Drug: Varenicline; Behavioral: Contingency Management; Behavioral: Behavioral Counseling

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Open-label trial; 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.

Drug: Varenicline; 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.; Other Names: Chantix; Behavioral: Contingency 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.; Other Names: monetary incentives; Behavioral: Behavioral 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Smoking Status	Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week	Assessed starting in week 2 of 12 weekly study visits

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Kelly E Dunn, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: IRB00071969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study was ended prematurely due to lack of recruitment. Data analysis is not possible and will not be reported.