Mobile Contingency Management for Smoking Cessation

Smoking Cessation Clinical Trial

— P3  

Official title:

Mobile Contingency Management for Smoking Cessation Among Socioeconomically Disadvantaged Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881630
• Other study ID #: 12881
• Secondary ID: R01CA251451
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: Shannon Gwin, Ph.D.
• Phone: 405-271-8001
• Email: Shannon-Gwin[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the proposed project is to evaluate an automated mobile phone-based CM approach that will allow socioeconomically disadvantaged individuals to remotely benefit from financial incentives for smoking cessation. The investigators have previously combined technologies including 1) portable carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to confirm participant identity during breath sample submissions, and 3) remote delivery of incentives automatically triggered by biochemical confirmation of self-reported abstinence. This automated CM approach will be evaluated in a randomized controlled trial that includes 532 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to either telephone counseling and nicotine replacement therapy (standard care [SC]) or SC plus a mobile financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will be followed for 26 weeks after a scheduled quit attempt. Biochemically-verified 7-day point prevalence abstinence at 26 weeks post-quit will be the primary outcome variable. Cost-effectiveness will be evaluated to inform policy-related decisions. Potential mobile CM treatment mechanisms, including self-efficacy, motivation, and treatment engagement, will be explored to optimize future versions of the intervention.

Description:

The primary purpose of the proposed project is to evaluate an automated smartphone-based CM approach that will allow socioeconomically disadvantaged adults to earn financial incentives for smoking cessation without requiring in-person attendance for abstinence verification. The investigators have combined technologies: 1) low-cost carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to verify the identity of participants while they provide a breath sample, and 3) remote and automated delivery of incentives to a credit card triggered by biochemical confirmation of self-reported smoking abstinence. This CM approach will be evaluated in a randomized controlled trial of 532 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to telephone counseling plus nicotine replacement therapy (standard care [SC]) or SC plus a 12-week smartphone-based financial incentives intervention (CM). Participants will be followed for 26 weeks after a scheduled quit attempt, which is 14 weeks after incentives have ended. Cost-effectiveness will be evaluated to inform policy and health care decisions. Potential CM treatment mechanisms, including self-efficacy, motivation, and treatment engagement will be identified to optimize future versions of the intervention. The specific aims are: 1) to evaluate the impact of an automated, mobile phone-based CM approach relative to SC on smoking cessation among socioeconomically disadvantaged adults, 2) to compare the cost-effectiveness of two smoking cessation interventions (CM vs. SC), and 3) to identify mobile CM treatment mechanisms such as motivation to quit, self-efficacy for quitting, and treatment engagement/adherence. The proposed study will evaluate an intervention approach that increases the reach of a potentially effective and cost-effective smoking cessation intervention for socioeconomically disadvantaged smokers. This proposed study is also going to be conducting recruitment nationwide.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 532
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. report an annual household income of <200% of the federal poverty threshold (i.e., low-income)

2. earn a score =4 on the REALM indicating >6th grade English literacy level (i.e., a 7th grade reading level is necessary to complete assessments)

3. are willing to quit smoking 7-14 days after enrollment

4. are = 18 years of age

5. currently smoke = 5 cigarettes per day

6. have a CO level of >6 ppm

7. are willing to abstain from smoking cannabis and other combustible tobacco products (they raise CO levels and mask cigarette abstinence)

8. have no contraindications for NRT

9. Provide a copy/photo of driver's license or other documentation as proof of identity and U.S. residence Exclusion Criteria 1) do not meet the specified inclusion criteria

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Automated Mobile Contingency Management (CM)
Financial incentives contingent upon smoking abstinence

Other:
• Standard Care (SC)
Tobacco cessation telephone counseling and combination nicotine replacement therapy (nicotine patches + nicotine gum/lozenges)

Locations

Country	Name	City	State
United States	TSET Health Promotion Research Center	Oklahoma City	Oklahoma

Sponsors (5)

Lead Sponsor	Collaborator
University of Oklahoma	H. Lee Moffitt Cancer Center and Research Institute, M.D. Anderson Cancer Center, National Cancer Institute (NCI), University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kendzor DE, Businelle MS, Vidrine DJ, Frank-Pearce SG, Shih YT, Dallery J, Alexander AC, Boozary LK, Waring JJC, Ehlke SJ. Mobile contingency management for smoking cessation among socioeconomically disadvantaged adults: Protocol for a randomized trial. Contemp Clin Trials. 2022 Mar;114:106701. doi: 10.1016/j.cct.2022.106701. Epub 2022 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carbon monoxide-verified smoking abstinence	The primary outcome measure is carbon monoxide-verified 7-day point prevalence abstinence at 26 weeks post-quit.	26 weeks post-quit-date
Secondary	Cost-effectiveness	The incremental cost effectiveness ratio (ICER) calculated as the difference in mean costs between the new (CM) and standard treatment (SC) divided by the difference in mean effectiveness between the two, estimates additional resources needed to achieve an increase of one unit of effectiveness. The ICER is then compared with published threshold values for cost-effective interventions. The cost model will include all necessary personnel, hardware, and material costs.	26 weeks post-quit-date
Secondary	Carbon monoxide-verified smoking abstinence	Carbon monoxide-verified 7-day point prevalence abstinence at 12 weeks post-quit-date.	12 week post-quit-date
Secondary	Carbon monoxide-verified smoking abstinence	Carbon monoxide-verified 7-day point prevalence abstinence at 8 weeks post-quit-date.	8 weeks post-quit-date
Secondary	Carbon monoxide-verified smoking abstinence	Carbon monoxide-verified 7-day point prevalence abstinence at 4 weeks post-quit-date.	4 weeks post-quit-date
Secondary	Carbon monoxide-verified smoking abstinence	Carbon monoxide-verified 30-day point prevalence abstinence at 26 weeks post-quit-date.	26 weeks post-quit-date