Pre to Postoperative Smoking Cessation

NCT02683161 | Terminated Phase 2 Results

• 1 other identifier: IRB00071969
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Open-label trial

OTHER

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; Behavioral: Contingency Management; Behavioral: Behavioral Counseling

Interventions

Varenicline DRUG

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.

Also known as: Chantix

Open-label trial

Contingency Management BEHAVIORAL

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.

Also known as: monetary incentives

Open-label trial

Behavioral Counseling BEHAVIORAL

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.

Open-label trial

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoker who has surgery scheduled 5-10 weeks in advance

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Obesity

Interventions

Varenicline; Behavior Therapy

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Kelly Dunn
• Organization: Johns Hopkins University

kdunn9@jhmi.edu

410-550-2254

Study Officials

• Kelly E Dunn, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: February 17, 2016
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 17, 2018
• Results First Posted: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)