Clinical trial NCT04881630: Mobile Contingency Management for Smoking Cessation
Official title: Mobile Contingency Management for Smoking Cessation Among Socioeconomically Disadvantaged Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking Cessation
Financial Incentives
Socioeconomic Status
Contingency Management
Mobile Health
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: M.D. Anderson Cancer Center
name: University of Florida
name: H. Lee Moffitt Cancer Center and Research Institute
First posted: 2021-05-11
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Carbon monoxide-verified smoking abstinence
timeFrame: 26 weeks post-quit-date
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 26 weeks post-quit-date
measure: Carbon monoxide-verified smoking abstinence
timeFrame: 12 week post-quit-date
measure: Carbon monoxide-verified smoking abstinence
timeFrame: 8 weeks post-quit-date
measure: Carbon monoxide-verified smoking abstinence
timeFrame: 4 weeks post-quit-date
measure: Carbon monoxide-verified smoking abstinence
timeFrame: 26 weeks post-quit-date
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: TSET Health Promotion Research Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Darla E. Kendzor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.