SmokingQUITNCT02565381

A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care for Homeless Smokers

A study testing Transdermal nicotine patch, In-person smoking cessation counseling and Contingent financial rewards for smoking abstinence in people with Smoking, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking
What is being tested?: Transdermal nicotine patch, In-person smoking cessation counseling and Contingent financial rewards for smoking abstinence
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 1 siteUnited States
Study dates: Oct 2015to Aug 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers.
Age ≥18 years old, assessed by self-report and verified by date of birth.
Has smoked ≥100 cigarettes and currently smokes ≥5 cigarettes per day, verified by an exhaled carbon monoxide level of ≥8 ppm.
Ready to try quitting smoking within the next month.
Currently homeless, assessed by self-report and defined as usually staying in an emergency shelter, transitional shelter, abandoned building, place of business, car or other vehicle, church or mission, hotel or motel, or anywhere outside during the past 7 days. Additionally, individuals will be considered currently homeless if they usually stayed in somebody else's house, apartment/condominium, or room in the past 7 days because of not having their own place to stay.

Who cannot join

Currently pregnant, assessed by a urine pregnancy test conducted on all premenopausal biologic females who have not had a hysterectomy, or planning to become pregnant in the next 2 months.
Past 30-day use of nicotine replacement therapy, bupropion, or varenicline for smoking cessation, assessed by self-report. Use of bupropion for reasons other than to quit smoking (e.g. depression) is permissible.
Prior serious adverse reaction to the nicotine patch, defined as any reaction that was life-threatening or required hospitalization.
Heart attack or chest pain within the past 2 weeks.
Inability to read a sentence written at a Flesch-Kincaid grade level of 4.
Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate.

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Health Care for the Homeless Program
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: The QUIT Smoking Study: A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care to Help Homeless Smokers Quit Smoking

The QUIT (Quitting with Usual Care, Incentives, and Technology) Smoking Study is a 3-arm pilot randomized controlled trial that will test the effect of 2 different experimental smoking cessation interventions relative to a control condition in homeless cigarette smokers. All participants will receive free transdermal nicotine patches and weekly in-person smoking cessation counseling. In addition, participants randomized to the first experimental condition will receive financial rewards for biochemically-verified smoking abstinence, and participants randomized to the second experimental condition will be enrolled in a text messaging program to support smoking abstinence.

Conditions: Smoking
Being tested: Transdermal nicotine patch, In-person smoking cessation counseling, Contingent financial rewards for smoking abstinence, Text messages to support smoking abstinence
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transdermal nicotine patchDrug
Also called Nicotine
- ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counselingBehavioural
- One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinenceBehavioural
Also called Contingency management
- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm
Text messages to support smoking abstinenceBehavioural
- 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT

Study groups in NCT02565381
Study group	Role	What they receive
Control (N=25)	Active comparator	* Transdermal nicotine patch * In-person smoking cessation counseling Receives: Drug: Transdermal nicotine patch; Behavioral: In-person smoking cessation counseling
Financial rewards (N=25)	Experimental	* Transdermal nicotine patch * In-person smoking cessation counseling * Contingent financial rewards for smoking abstinence Receives: Drug: Transdermal nicotine patch; Behavioral: In-person smoking cessation counseling; Behavioral: Contingent financial rewards for smoking abstinence
Text messaging (N=25)	Experimental	* Transdermal nicotine patch * In-person smoking cessation counseling * Text messages to support smoking abstinence Receives: Drug: Transdermal nicotine patch; Behavioral: In-person smoking cessation counseling; Behavioral: Text messages to support smoking abstinence

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide <8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks)
Measured: Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period

Secondary outcomes (7)

Percentage of Visits Abstinent of Smoking
Percentage of 14 assessment visits at which a participant is abstinent of smoking, defined as an exhaled carbon monoxide level <8ppm.
Measured: 8 weeks
Smoking Abstinence at End of Study
Point-prevalence smoking abstinence, defined as an exhaled carbon monoxide level <8ppm, at the 14th (final) study visit.
Measured: 8 weeks
Change in Cigarette Consumption
Changes in the average number of cigarettes per day relative to baseline, defined by self-report and repeatedly assessed at the 8 assessment visits occurring on Fridays.
Measured: Once per week for 8 weeks
Change in Behavioral Health
Past-month drug use severity (score range 0-1), past-month alcohol use severity (score range 0-1), and past-month psychiatric severity (0-1) were each assessed with the Addiction Severity Index (ASI) - 5th Edition, at baseline and at the 10th and 14th study visits. For each ASI measure, higher scores represent greater drug, alcohol, or psychiatric severity. Changes in ASI scores between baseline and 4 or 8 weeks can range from -1 to +1. When interpreting changes in scores, negative values indicate decreases in scores from baseline to 4 or 8 weeks, and positive values indicate increases in scores from baseline to 4 or 8 weeks.
Measured: 4 weeks and 8 weeks
Study Visit Attendance
Percentage of 14 assessment visits attended.
Measured: 8 weeks
Counseling Visit Attendance
Percentage of 8 counseling visits attended.
Measured: 8 weeks
Nicotine Patch Use
Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Aug 2016

First posted1 Oct 2015 (estimated)
Study startOct 2015
Primary completionJun 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02565381
Sponsor's protocol ID: 2015P001300
Other IDs: K23DA034008
Acronym: QUIT
Status last verified: Jun 2017
First submitted: 29 Sep 2015
Last updated: 14 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Baggett TP, McGlave C, Kruse GR, Yaqubi A, Chang Y, Rigotti NA. SmokefreeTXT for Homeless Smokers: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 4;7(6):e13162. doi: 10.2196/13162.
PubMed 31165717
Baggett TP, Yaqubi A, Berkowitz SA, Kalkhoran SM, McGlave C, Chang Y, Campbell EG, Rigotti NA. Subsistence difficulties are associated with more barriers to quitting and worse abstinence outcomes among homeless smokers: evidence from two studies in Boston, Massachusetts. BMC Public Health. 2018 Apr 10;18(1):463. doi: 10.1186/s12889-018-5375-z.
PubMed 29631559
Baggett TP, Chang Y, Yaqubi A, McGlave C, Higgins ST, Rigotti NA. Financial Incentives for Smoking Abstinence in Homeless Smokers: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2018 Nov 15;20(12):1442-1450. doi: 10.1093/ntr/ntx178.
PubMed 29059442

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The QUIT Smoking Study: A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care to Help Homeless Smokers Quit Smoking
ClinicalTrials.gov ID: NCT02565381
Acronym / sponsor ID: QUIT / 2015P001300
Conditions: Smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Oct 2015 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 1 Oct 2015 (estimated)
Results: Posted 14 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control (N=25)	Active comparator	Drug: Transdermal nicotine patch, Behavioral: In-person smoking cessation counseling* Transdermal nicotine patch * In-person smoking cessation counseling
Financial rewards (N=25)	Experimental	Drug: Transdermal nicotine patch, Behavioral: In-person smoking cessation counseling, Behavioral: Contingent financial rewards for smoking abstinence* Transdermal nicotine patch * In-person smoking cessation counseling * Contingent financial rewards for smoking abstinence
Text messaging (N=25)	Experimental	Drug: Transdermal nicotine patch, Behavioral: In-person smoking cessation counseling, Behavioral: Text messages to support smoking abstinence* Transdermal nicotine patch * In-person smoking cessation counseling * Text messages to support smoking abstinence

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers.
Age ≥18 years old, assessed by self-report and verified by date of birth.
Has smoked ≥100 cigarettes and currently smokes ≥5 cigarettes per day, verified by an exhaled carbon monoxide level of ≥8 ppm.
Ready to try quitting smoking within the next month.
Currently homeless, assessed by self-report and defined as usually staying in an emergency shelter, transitional shelter, abandoned building, place of business, car or other vehicle, church or mission, hotel or motel, or anywhere outside during the past 7 days. Additionally, individuals will be considered currently homeless if they usually stayed in somebody else's house, apartment/condominium, or room in the past 7 days because of not having their own place to stay.

Key exclusion criteria (6 listed)

Currently pregnant, assessed by a urine pregnancy test conducted on all premenopausal biologic females who have not had a hysterectomy, or planning to become pregnant in the next 2 months.
Past 30-day use of nicotine replacement therapy, bupropion, or varenicline for smoking cessation, assessed by self-report. Use of bupropion for reasons other than to quit smoking (e.g. depression) is permissible.
Prior serious adverse reaction to the nicotine patch, defined as any reaction that was life-threatening or required hospitalization.
Heart attack or chest pain within the past 2 weeks.
Inability to read a sentence written at a Flesch-Kincaid grade level of 4.

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
Transdermal nicotine patchAlso: Nicotine* ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks * <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks	Drug	Control (N=25), Financial rewards (N=25), Text messaging (N=25)
In-person smoking cessation counseling- One-on-one 15-minute counseling sessions once per week for 8 weeks	Behavioural	Control (N=25), Financial rewards (N=25), Text messaging (N=25)
Contingent financial rewards for smoking abstinenceAlso: Contingency management- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm	Behavioural	Financial rewards (N=25)
Text messages to support smoking abstinence- 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT	Behavioural	Text messaging (N=25)

Primary outcome

Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
Time frame: Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period
The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide <8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks)

7 secondary outcomes

Percentage of Visits Abstinent of Smoking
Time frame: 8 weeks
Smoking Abstinence at End of Study
Time frame: 8 weeks
Change in Cigarette Consumption
Time frame: Once per week for 8 weeks
Change in Behavioral Health
Time frame: 4 weeks and 8 weeks
Study Visit Attendance
Time frame: 8 weeks
Counseling Visit Attendance
Time frame: 8 weeks
Nicotine Patch Use
Time frame: 8 weeks

Results and safety

Results posted to the registry on 14 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control (N=25)	25	24
Financial Rewards (N=25)	25	25
Text Messaging (N=25)	25	24

Primary outcome: Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks

Time frame: Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period. Count of participants. Unit: Participants

Measure	Control (N=25) n = 25	Financial Rewards (N=25) n = 25	Text Messaging (N=25) n = 25
Day 3	3	10	3
Day 5	0	9	1
Day 7	4	15	3
Day 10	4	15	2
Day 12	5	17	4
Day 14	4	15	4
Day 17	3	13	4
Day 21	2	14	3

Population analysed: Participants with missing data at a given time point were assumed non-abstinent at that time point.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the 8-week study period for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control (N=25)	0 of 25 (0%)	1 of 25 (4%)	0 of 25
Financial Rewards (N=25)	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Text Messaging (N=25)	0 of 25 (0%)	5 of 25 (20%)	0 of 25

Limitations and caveats (from the sponsor): Small sample size; short duration of follow-up; primary outcome based exclusively on exhaled carbon monoxide measurement.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31165717Baggett TP, McGlave C, Kruse GR, Yaqubi A, Chang Y, Rigotti NA. SmokefreeTXT for Homeless Smokers: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 4;7(6):e13162. doi: 10.2196/13162.
Derived from this study: PubMed 29631559Baggett TP, Yaqubi A, Berkowitz SA, Kalkhoran SM, McGlave C, Chang Y, Campbell EG, Rigotti NA. Subsistence difficulties are associated with more barriers to quitting and worse abstinence outcomes among homeless smokers: evidence from two studies in Boston, Massachusetts. BMC Public Health. 2018 Apr 10;18(1):463. doi: 10.1186/s12889-018-5375-z.
Derived from this study: PubMed 29059442Baggett TP, Chang Y, Yaqubi A, McGlave C, Higgins ST, Rigotti NA. Financial Incentives for Smoking Abstinence in Homeless Smokers: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2018 Nov 15;20(12):1442-1450. doi: 10.1093/ntr/ntx178.

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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.

Travis P Baggett, MD, MPH principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: finished, as of the sponsor's last update on 14 Jul 2017. 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?

Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks (time frame: Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02565381, which also lists 3 linked publications.

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 14 Jul 2017.