Incentives to Promote Smoking Cessation in Low SES Women (ProjectMIST)

The purpose of this study is to investigate the feasibility of a mobile-phone based contingency management (CM) intervention for smoking in low-SES women. The CM intervention will be combined with a Brief Motivational Interviewing (BMI) counseling component. This study will examine the following research aims:

Primary Aim: To compare the effects of a Brief Motivational Intervention (BMI) + mobile phone-based CM on tobacco use when compared to BMI with a non-contingent control condition in a small feasibility trial.

Hypothesis: The investigators expect women in the BMI + CM condition to have more smoke free days than women in the BMI + NC condition.

Secondary Aim: To examine alcohol use as a moderator of cessation outcomes.

Study Overview

• Status: Terminated
• Conditions: Nicotine Dependence
• Intervention / Treatment: Behavioral: Brief Motivational Intervention; Behavioral: Contingency Management; Behavioral: Non-Contingent Reinforcement

Detailed Description

Cigarette smoking is the leading cause of preventable death in the United States, accounting for one out of every five deaths (CDC, 2012). In particular, smoking prevalence rates are high among socioeconomically-disadvantaged women; for example, over 40% of women with less than 12 yrs education smoke, compared to 28% and 16% among those with some college and undergraduate degrees (SAMHSA, 2010). Smoking cessation rates are particularly low among low-SES women with co-occurring alcohol use disorders, and these substances are frequently used together (Kahler et al., 2010; Businelle et al., 2013). Therefore, interventions that reduce both alcohol and smoking among heavy alcohol-using women are vitally needed to reduce rates of smoking-related morbidity and mortality in this vulnerable population.

Counseling approaches that incorporate problem solving, skills training and social support are effective for reducing smoking in the general population (Fiore et al., 2008). However, given the high rates of smoking among alcohol-using women, they may be inadequate for in this population. Contingency management (CM) interventions, which provide tangible reinforcers contingent upon smoking abstinence or reduction to a criterion level, are highly-efficacious interventions for reducing cigarette smoking and other drug use in low-SES women (Higgins et al., 2012). Within the theoretical framework of operant conditioning, increasing the availability of an alternative reinforcer weakens the amount of control that the drug has over the user's behavior, especially when obtaining the alternative reinforcer is contingent on behaviors incompatible with drug use (Higgins, 1997). The tenets of CM interventions include (1) arranging the environment such that the target behavior can be readily and objectively detected, (2) providing a tangible reinforcer when the target behavior occurs, and (3) withholding reinforcement when the target behavior does not occur (Higgins et al., 1994).

Although CM interventions clearly are effective at promoting smoking reductions, there are several challenges associated with translating CM into an effective clinical treatment for smoking. Perhaps the most significant challenge is the frequent monitoring necessary to objectively verify smoking abstinence using breath carbon monoxide (CO), the most convenient objective measure of smoking status. Because of the short half-life of CO (5-6 hours), CO levels must be measured at least twice per day in order to verify continuous abstinence. Recent CM-smoking studies have addressed this feasibility challenge by providing study participants with breath CO monitors and laptop computers or smartphones to use in their own natural environments (e.g., Dallery, Raiff & Grabinski, 2013). Participants are taught how to use their smartphones to text videos of themselves providing a breath CO level to a research staff member, twice per day. After the study staff has determined that the breath CO sample meets the abstinence criterion, participants are informed of the amount that they have earned for that sample.

Given the high rates of smoking in low-SES women, investigating the additive impact of an in-person brief counseling intervention and a phone-based CM intervention is an important next step in examining effective methods to reduce the impact of smoking in this population.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age 18+
• Smoke an average of at least ten cigarettes per day for at least 1 year
• Breath CO levels > 8 ppm
• >12 years of education
• Reliable and consistent access to a smart phone with video messaging capabilities

Exclusion Criteria:

• Intention to quit smoking in the next 30 days
• Currently seeking treatment for smoking cessation.
• Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
• No reliable access to a video-messaging smart phone
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management (CM); Those in the CM condition will continue to provide CO values twice-daily, and will receive escalating reinforcement values for CO values indicating continuous smoking abstinence (CO < 6 ppm).	Behavioral: Brief Motivational Intervention; Participants in both groups will be given an BMI intervention in which they will be counseled to quit smoking.; Behavioral: Contingency Management; Contingent Reinforcement for negative breath CO samples
Active Comparator: Non-Contingent Reinforcement; Participants in the NC condition will also provide CO levels twice-daily. However, their reinforcement will not be contingent upon their CO level but will be yoked to someone in the CM condition so that average reinforcer values are equivalent across the 2 conditions.	Behavioral: Brief Motivational Intervention; Participants in both groups will be given an BMI intervention in which they will be counseled to quit smoking.; Behavioral: Non-Contingent Reinforcement; Participants will receive reinforcement for submitting samples ona yoked schedule unrelated to CO sample value [CM control]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of negative CO samples	The amount of negative, decreased CO samples submitted by participants	End of two-week intervention

Collaborators and Investigators

• Sponsor: Brown University

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): March 3, 2018
• Study Completion (Actual): March 3, 2018

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 5-24001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No