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

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ClinicalTrials.gov Identifier: NCT02565381
Recruitment Status : Completed
First Posted : October 1, 2015
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Travis Paul Baggett, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Drug: Transdermal nicotine patch Behavioral: In-person smoking cessation counseling Behavioral: Contingent financial rewards for smoking abstinence Behavioral: Text messages to support smoking abstinence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control (N=25)
  • Transdermal nicotine patch
  • In-person smoking cessation counseling
Drug: Transdermal nicotine patch
  • ≥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
Other Name: Nicotine

Behavioral: In-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks

Experimental: Financial rewards (N=25)
  • Transdermal nicotine patch
  • In-person smoking cessation counseling
  • Contingent financial rewards for smoking abstinence
Drug: Transdermal nicotine patch
  • ≥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
Other Name: Nicotine

Behavioral: In-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks

Behavioral: Contingent financial rewards for smoking abstinence
- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm
Other Name: Contingency management

Experimental: Text messaging (N=25)
  • Transdermal nicotine patch
  • In-person smoking cessation counseling
  • Text messages to support smoking abstinence
Drug: Transdermal nicotine patch
  • ≥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
Other Name: Nicotine

Behavioral: In-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks

Behavioral: 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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Percentage of Visits Abstinent of Smoking [ Time Frame: 8 weeks ]
    Percentage of 14 assessment visits at which a participant is abstinent of smoking, defined as an exhaled carbon monoxide level <8ppm.

  2. Smoking Abstinence at End of Study [ Time Frame: 8 weeks ]
    Point-prevalence smoking abstinence, defined as an exhaled carbon monoxide level <8ppm, at the 14th (final) study visit.

  3. Change in Cigarette Consumption [ Time Frame: Once per week for 8 weeks ]
    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.

  4. Change in Behavioral Health [ Time Frame: 4 weeks and 8 weeks ]
    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.

  5. Study Visit Attendance [ Time Frame: 8 weeks ]
    Percentage of 14 assessment visits attended.

  6. Counseling Visit Attendance [ Time Frame: 8 weeks ]
    Percentage of 8 counseling visits attended.

  7. Nicotine Patch Use [ Time Frame: 8 weeks ]
    Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays.


Other Outcome Measures:
  1. Recruitment Time [ Time Frame: Until target number of participants is reached; anticipate ~6 months ]
    Total time to recruit, enroll, and randomize 75 study participants.

  2. Mobile Phone Retention [ Time Frame: 8 weeks ]
    Percentage of participants who still have their mobile phone at the end of the study.

  3. Use of Text Messaging Program [ Time Frame: 8 weeks ]
    Text messaging group only: number who enrolled in SmokefreeTXT, number who replied to query texts sent by SmokefreeTXT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565381


Locations
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United States, Massachusetts
Boston Health Care for the Homeless Program
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Travis P Baggett, MD, MPH Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Travis Paul Baggett, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02565381    
Other Study ID Numbers: 2015P001300
K23DA034008 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2015    Key Record Dates
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action