Changing the Default for Tobacco Treatment

NCT02721082 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: STUDY00001774R01HL131512
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.

Conditions

Tobacco Use Cessation

Keywords

tobacco treatment

Outcome Measures

Primary Outcomes (1)

• 7-day Point-prevalence Abstinence

  7-day, self-reported and verified cigarette abstinence.

  Month 1

Secondary Outcomes (3)

• Treatment Engagement

  Month 1

• Default-theory Based Measures

  Month 1

• 7-day Point-prevalence Abstinence

  Month 6

Other Outcomes (1)

• Cost-effectiveness

  Month 6

Study Arms (2)

Opt Out

EXPERIMENTAL

Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.

Behavioral: Opt Out Treatment Program; Drug: Nicotine Replacement Therapy

Opt In

ACTIVE COMPARATOR

Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.

Behavioral: Opt In Treatment Program; Drug: Nicotine Replacement Therapy

Interventions

Opt Out Treatment Program BEHAVIORAL

Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.

Opt Out

Nicotine Replacement Therapy DRUG

Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.

Also known as: Nicotine patch, Nicotine mini-lozenges, Nicotine gum

Opt Out

Opt In Treatment Program BEHAVIORAL

Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.

Opt In

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Speak English or Spanish
• Have access to a telephone or mobile phone
• Not be currently pregnant or breast feeding
• Have no significant co-morbidity that precludes participation
• Current daily smoker
• Not in treatment for tobacco dependence
• Reside in Kansas or Missouri

You may not qualify if:

• Admission greater than 3 days

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (3)

• Richter KP, Catley D, Gajewski BJ, Faseru B, Shireman TI, Zhang C, Scheuermann TS, Mussulman LM, Nazir N, Hutcheson T, Shergina E, Ellerbeck EF. The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial. JAMA Intern Med. 2023 Apr 1;183(4):331-339. doi: 10.1001/jamainternmed.2022.7170.

  PMID: 36848129 DERIVED

• Faseru B, Mussulman LM, Nazir N, Ellerbeck EF, Shergina E, Scheuermann TS, Gajewski BJ, Catley D, Richter KP. Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment. Subst Abus. 2022;43(1):1035-1042. doi: 10.1080/08897077.2022.2060441.

  PMID: 35435813 DERIVED

• Faseru B, Ellerbeck EF, Catley D, Gajewski BJ, Scheuermann TS, Shireman TI, Mussulman LM, Nazir N, Bush T, Richter KP. Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial. Trials. 2017 Aug 14;18(1):379. doi: 10.1186/s13063-017-2119-9.

  PMID: 28806908 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Nicotine Replacement Therapy; Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Kimber Richter
• Organization: U. Kansas Medical Center

krichter@kumc.edu

9134490157

Study Officials

• Kimber Richter, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 28, 2016
• Study Start: September 1, 2016
• Primary Completion: July 27, 2020
• Study Completion: December 9, 2020
• Last Updated: December 1, 2022
• Results First Posted: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)