Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Contingency Management for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04982952
Recruitment Status : Not yet recruiting
First Posted : July 29, 2021
Last Update Posted : October 4, 2021
Sponsor:
Collaborator:
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The prevalence of smoking in the homeless population (70%) is over 4 times that of the general population (15%). Homeless adults have not experienced similar declines in tobacco use as the general population has over the past three decades. Homeless adults are interested in smoking cessation and make quit attempts, but are less successful in quitting smoking than the general population. Trials of group behavioral counseling and pharmacotherapy for smoking cessation have not led to substantial long-term abstinence (i.e., abstinence for 6 months or more), suggesting that these interventions alone are insufficient to improve quit rates among homeless adults. Many homeless adults seek health care in safety net clinics; these clinics could bring cessation interventions to scale. Contingency management is a powerful behavior change intervention that reinforces positive health behaviors through the provision of modest incentives (e.g., cash). In this pilot randomized controlled trial, the investigator will test the feasibility and acceptability of a contingency management intervention that provides incentives for smoking cessation for people experiencing homelessness.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking, Tobacco Smoking Reduction Behavioral: Contingency Management - Increasing Behavioral: Fixed payments Not Applicable

Detailed Description:

In this pilot randomized controlled trial (RCT), the investigator will (1) adapt a known-efficacious extended CM cessation intervention to a novel population and setting, with the ultimate goal of increasing long-term abstinence among homeless adults seeking care in safety net health clinics, (2) develop a corresponding RCT protocol, and (3) conduct a pilot RCT to assess the feasibility and acceptability of the RCT. If the pilot RCT is feasible and acceptable, the investigator will test the adapted intervention in a subsequently-funded, full-scale RCT.

Primary Objectives:

Assess feasibility and acceptability of a CM intervention through:

  1. Measuring biochemically-verified point prevalence abstinence at 6 months follow-up.
  2. Measuring participant adherence to the protocol.
  3. Gathering information on the number of visits attended.
  4. Assessing the retention protocol.

Secondary Objectives

Assess feasibility and acceptability of a CM intervention through:

  1. Biochemically-verified 7-day point months follow-up at 3 months.
  2. Prolonged abstinence at 3 months and 6 months follow-up.
  3. Point-prevalent abstinence at 12 months

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization into one of 2 groups will be stratified by recruiter and a binary nicotine dependency code
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Randomized Trial of a Contingency Management Smoking Cessation Intervention for Homeless Adults
Estimated Study Start Date : October 15, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Contingency Management (CM)
In addition to receiving usual cessation care at the Tom Waddell Urban Health Center (TWUHC), CM intervention participants with CO-verified abstinence will obtain a CM incentive payment, via gift cards and/or cash redeemable in national retail chains.
Behavioral: Contingency Management - Increasing
Increasing incentive payment for abstinent participant

Control Group
Participants who choose to attend smoking cessation in the usual care setting at TWUHC will receive a basic $5 payment for attending each study visit.
Behavioral: Fixed payments
Fixed payments for attending study visits




Primary Outcome Measures :
  1. Proportion of participants who achieve point prevalence abstinence [ Time Frame: 6 months ]
    The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm), and (3) urinary anatabine/anabasine assay levels < 2 nanograms per milliliter (ng/ml).

  2. Median number of carbon monoxide (CO) negative samples [ Time Frame: 6 months ]
    The total number of negative CO specimen samples collected throughout the first 6 months of the program will be reported with 24 maximum possible number of samples per person.

  3. Median total number of counseling sessions attended [ Time Frame: 6 months ]
    The number of counseling sessions attended per person will will recorded with a maximum of 5 sessions total.

  4. Proportion of the sample retained as a result of retention procedures over time [ Time Frame: Up to 12 months ]
    The proportion of participants who choose to attend cessation sessions visits at 2 weeks, 1 month, 3 months, 6 months, and 12 months. A participant will be considered lost to follow-up and censored on their last visits if the participants have failed to return for a scheduled visit and the study staff are unable to contact the participant after at least 3 attempts.


Secondary Outcome Measures :
  1. Proportion of participants who achieve point prevalence abstinence [ Time Frame: 3 months ]
    The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm)

  2. Proportion of participants who achieve point prevalence abstinence [ Time Frame: 12 months ]
    The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm)

  3. Proportion of participants who achieve prolonged abstinence over time [ Time Frame: Up to 6 months ]
    Prolonged abstinence is defined as participants (1) not smoking a single cigarette since the last visit; (2) having CO levels <=5 ppm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Are 18 years or older
  2. Engaged in care at the Tom Waddell Urban Health Center (TWUHC)
  3. Meet criteria for homelessness as defined by the Homeless Emergency Assistance and Rapid Transition to Housing Act
  4. Are current smokers (smoked at least 100 cigarettes in lifetime, smoked daily in the past 7 days and at least 5 cigarettes per day, verified by expired Carbon Monoxide (CO) >= 8 parts per million (ppm))
  5. Have an intention to quit smoking within the next six months
  6. Are attending on-site smoking cessation counseling provided by the behavioral counselors
  7. Are English proficient
  8. Are able to provide informed consent. Patients who are interested in participating but not enrolled in counseling services will be encouraged to engage in counseling sessions at the time of enrollment.

Exclusion Criteria:

1. Are unable to take nicotine replacement therapy (e.g., pregnancy or myocardial infarction (MI) within the past 2 weeks)


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): NCT04982952


Contacts
Layout table for location contacts
Contact: Jordan Cuby, MPH (415) 818-4469 Jordan.Cuby@ucsf.edu
Contact: Maya Vijayaraghavan, MD, MAS (628) 206-6959 Maya.Vijayaraghavan@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Jordan Cuby, MPH    415-818-4469    jordan.cuby@ucsf.edu   
Contact    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Maya Vijayaraghavan, MD, MAS         
Sponsors and Collaborators
University of California, San Francisco
Tobacco Related Disease Research Program
Investigators
Layout table for investigator information
Principal Investigator: Maya Vijayaraghavan, MD, MAS University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04982952    
Other Study ID Numbers: 21632
NCI-2021-08359 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Contingency Management