AzTrials
AzTrials

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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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
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

Other trials in United States

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.

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 groups in NCT03173274
Study groupRoleWhat they receive
Contingency Management (CM)ExperimentalThose 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 ReinforcementActive comparatorParticipants 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.

  1. 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.

  1. First posted1 Jun 2017
  2. Study start8 Feb 2018
  3. Primary completion3 Mar 2018
  4. Study completion3 Mar 2018

Why it stopped: Grant funding ended for pilot work

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in