Nicotine DependenceProjectMISTNCT03173274
Incentives to Promote Smoking Cessation in Low SES Women
A study testing Brief Motivational Intervention, Contingency Management and Non-Contingent Reinforcement in people with Nicotine Dependence, run by Brown University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Brief Motivational Intervention, Contingency Management and Non-Contingent Reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 3 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Nicotine Dependence
- Being tested
- Brief Motivational Intervention, Contingency Management, Non-Contingent Reinforcement
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterventionBehavioural
Participants in both groups will be given an BMI intervention in which they will be counseled to quit smoking.
Contingency ManagementBehavioural
Contingent Reinforcement for negative breath CO samples
Non-Contingent ReinforcementBehavioural
Participants will receive reinforcement for submitting samples ona yoked schedule unrelated to CO sample value [CM control]
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management (CM) | Experimental | 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). Receives: Behavioral: Brief Motivational Intervention; Behavioral: Contingency Management |
| Non-Contingent Reinforcement | Active comparator | 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. Receives: Behavioral: Brief Motivational Intervention; Behavioral: Non-Contingent Reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of negative CO samples
The amount of negative, decreased CO samples submitted by participants
Measured: End of two-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start8 Feb 2018
- Primary completion3 Mar 2018
- Study completion3 Mar 2018
Why it stopped: Grant funding ended for pilot work
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel N Cassidy, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173274
- Sponsor's protocol ID
- 5-24001
- Acronym
- ProjectMIST
- Status last verified
- Feb 2019
- First submitted
- 24 May 2017
- Last updated
- 4 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentives to Promote Smoking Cessation in Low SES Women
- ClinicalTrials.gov ID
- NCT03173274
- Acronym / sponsor ID
- ProjectMIST / 5-24001
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant funding ended for pilot work
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 3 Mar 2018 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management (CM) | Experimental | Behavioral: Brief Motivational Intervention, Behavioral: Contingency ManagementThose 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). |
| Non-Contingent Reinforcement | Active comparator | Behavioral: Brief Motivational Intervention, Behavioral: Non-Contingent ReinforcementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Motivational InterventionParticipants in both groups will be given an BMI intervention in which they will be counseled to quit smoking. | Behavioural | Contingency Management (CM), Non-Contingent Reinforcement |
| Contingency ManagementContingent Reinforcement for negative breath CO samples | Behavioural | Contingency Management (CM) |
| Non-Contingent ReinforcementParticipants will receive reinforcement for submitting samples ona yoked schedule unrelated to CO sample value [CM control] | Behavioural | Non-Contingent Reinforcement |
Primary outcome
Percent of negative CO samples
Time frame: End of two-week intervention
The amount of negative, decreased CO samples submitted by participants
Results and safety
The study was stopped early (reason given: Grant funding ended for pilot work). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Nicotine Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention, Contingency Management and Non-Contingent Reinforcement in people with Nicotine Dependence, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Grant funding ended for pilot work). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of negative CO samples (time frame: End of two-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.