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Tobacco Use CessationPhase 2/3PRISM-SCCSNCT03521141

PRecision Interventions for SMoking in the SCCS

A Phase 2/3 study testing Nicotine patch, Varenicline and Nicotine metabolism in people with Tobacco Use Cessation, run by Vanderbilt University Medical Center 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

Precision Care (PC) interventions, developed with guidance from a Community Advisory Board (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible, consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to make a quit attempt with medication and who… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tobacco Use Cessation
What is being tested?
Nicotine patch, Varenicline and Nicotine metabolism
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteUnited States
Study dates
18 May 2018to 25 Apr 2019
Phase
Phase 2/3
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

  • Daily smoker of ≥5 cigarettes per day (CPD)
  • Enrolled participant of the Southern Community Cohort Study (SCCS) who completed a prior survey indicating they were willing to be contacted regarding a smoking cessation clinical trial
  • Residence in Tennessee (TN) or Mississippi (MS)
  • Has stored blood sample with the SCCS
  • Has established primary care provider (PCP)
  • Medically eligible and willing to take varenicline and NRT

Who cannot join

  • Currently taking medication to quit smoking
  • enrolled, or planning to be enrolled, in another smoking cessation program
  • Inability to give informed consent or participate due to cognitive disorder (e.g., dementia, severe intellectual disability)
  • Unstable psychiatric illness (ER or hospitalized for psychiatric condition in past 6 months, change in psychiatric medications in past 3 months, or suicidal ideation in past 6 months)
  • not able to send or receive mail
  • no access to a telephone or inability to communicate by telephone
Show all 9Show fewer
  • unable to speak and read English
  • history of seizures or Buerger's disease
  • currently pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Developing Precision Smoking Treatment in the Southern Community Cohort Study

Precision Care (PC) interventions, developed with guidance from a Community Advisory Board (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible, consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to make a quit attempt with medication and who reside in TN or MS. Participants will be randomized 1:1:1 to 1 of 3 groups; (1) group one informs selection of medication with information on nicotine metabolism; (2) group two offers a genetically-informed lung cancer risk score, and (3) group 3 is Guideline-Based Care (GBC). All groups will be followed for 6 months. All RCT participants will receive FDA-approved smoking cessation medication, be referred to the shared TN/MS state quitline, and be offered the NCI "Clearing the Air" standard intervention. The primary outcome is feasibility of delivering the precision interventions in the SCCS population, as evidenced by ability to recruit, engage, and retain participants through end of study. Secondary outcomes, for which the study is not powered, will include risk perceptions, use of quit aids, lung cancer screening among those who are eligible, and smoking cessation.

Read the detailed description

Cigarette smoking significantly increases the risk of cancer and improved cessation strategies are needed. Biologically-informed precision treatment could benefit smokers but is understudied.

Tennessee and Mississippi Smokers that responded to a previous survey indicating willingness to be contacted for a smoking cessation clinical trial will be assessed for eligibility via phone and, if eligible, provide verbal consent and administer a baseline survey. These participants will then mail in written consent, upon receipt of which their SCCS stored blood samples will be analyzed. During lab processing, a study tobacco counselor will call enrolled participants to assist with their quit plan and inform them of randomization status. Participants will complete telephone surveys at 1, 3, and 6 months. During the 6 month follow-up call, participants will also be given their previously-unreported lab results (i.e., information on nicotine metabolism or lung cancer risk). After receiving lab results, participants will complete a final brief questionnaire.

Being tested
Nicotine patch, Varenicline, Nicotine metabolism, Genetically-informed lung cancer risk score, NCI "Clearing the Air"
Keywords
Tobacco Use Cessation, Precision Medicine
Medical subject headings
Tobacco Use Cessation

What participants receive

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

  • Nicotine patchDrug

    Also called Nicotine Replacement Therapy

    FDA-approved smoking cessation pharmacotherapy

  • VareniclineDrug

    Also called Chantix

    FDA-approved smoking cessation pharmacotherapy

  • Nicotine metabolismGenetic

    Information on nicotine metabolism will be used to inform selection of medication.

  • Genetically-informed lung cancer risk scoreGenetic

    This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.

  • NCI "Clearing the Air"Behavioural

    A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle.

Study groups in NCT03521141
Study groupRoleWhat they receive
Guideline-Based Care (GBC)OtherGBC participants are 1) referred to the state quitline, 2) provided the NCI Clearing the Air smoking cessation program, and 3) asked to talk to their healthcare provider about potential lung cancer screening (LCS). Medication assignment is guided by standard guidelines and a conversation between the study tobacco counselor and the participant. Groups 1 and 2 also receive GBC counseling.
Receives: Drug: Nicotine patch; Drug: Varenicline; Behavioral: NCI "Clearing the Air"
Nicotine Metabolite Ratio (PC-NMR)Active comparatorGroup 1, nicotine metabolism. Medication is guided by nicotine metabolism.
Receives: Drug: Nicotine patch; Drug: Varenicline; Genetic: Nicotine metabolism; Behavioral: NCI "Clearing the Air"
Respiragene (PC-Respiragene)Active comparatorGroup 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.
Receives: Drug: Nicotine patch; Drug: Varenicline; Genetic: Genetically-informed lung cancer risk score; Behavioral: NCI "Clearing the Air"

What is being measured

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

  1. Intervention Feasibility: Ability to Retain Participants

    Feasibility of delivering precision care (PC) interventions in the Southern Community Cohort Study (SCCS), as evidenced by ability to recruit, engage, and retain participants through end of the study.

    Measured: Full trial: Baseline - 6 month survey

Secondary outcomes (5)

  1. Cessation History - Quit Attempts

    Participants who reported making a quit attempt during the trial, as defined by use of a quit aid or reporting "not at all" for current smoking at any timepoint

    Measured: Full trial: Baseline - 6 month survey

  2. Cessation History - Medication Use

    Participants who received, and those who subsequently used, a smoking cessation medication during the trial

    Measured: Full trial: Baseline - 6 month survey

  3. Cessation History - Quitline

    Participants who reported using the quitline ("phone support") at any point during the trial

    Measured: Full trial: Baseline - 6 month survey

  4. Cessation History - Self-reported Abstinence

    Participants who self-reported abstinence at the 6 month survey

    Measured: 6 months

  5. Cessation History - Validated Abstinence

    Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml)

    Measured: 6 months

Timeline

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

  1. First posted11 May 2018
  2. Study start18 May 2018
  3. Primary completion11 Apr 2019
  4. Study completion25 Apr 2019

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Assessing parallel precision care interventions (groups 1, 2) and control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03521141
Sponsor's protocol ID
160331
Other IDs
16-06-571, HS2016-3815
Acronym
PRISM-SCCS
Status last verified
May 2020
First submitted
27 Apr 2018
Last updated
1 Jun 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data (IPD) available to other researchers or institutions.

Publications

  • Lee SS, Senft Everson N, Sanderson M, Selove R, Blot WJ, King S, Gilliam K, Kundu S, Steinwandel M, Sternlieb SJ, Cai Q, Warren Andersen S, Friedman DL, Connors Kelly E, Fadden MK, Freiberg MS, Wells QS, Canedo J, Tyndale RF, Young RP, Hopkins RJ, Tindle HA. Feasibility of precision smoking treatment in a low-income community setting: results of a pilot randomized controlled trial in The Southern Community Cohort Study. Addict Sci Clin Pract. 2024 Mar 15;19(1):16. doi: 10.1186/s13722-024-00441-1.

    PubMed 38491559

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nicotine patch, Varenicline and Nicotine metabolism in people with Tobacco Use Cessation, run by Vanderbilt University Medical Center 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 6 inclusion and 9 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 1 Jun 2020. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2020). 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?

Intervention Feasibility: Ability to Retain Participants (time frame: Full trial: Baseline - 6 month survey). 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 NCT03521141, which also lists 1 linked publication.

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 1 Jun 2020.

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