Tobacco SmokingPhase 4NCT03620708
Tobacco and Socioeconomic Disadvantage
A Phase 4 study testing Motivational Interviewing, Nicotine Replacement Therapy Sampling and Referral Only in people with Tobacco Smoking, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Motivational Interviewing, Nicotine Replacement Therapy Sampling and Referral Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 1 Oct 2018
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be between the age of 19 and 65
- Participants must self-report being a daily smoker and provide biochemical verification of smoking status (expired breath carbon monoxide reading >5)
- Participants must be at socioeconomic disadvantage, defined as receiving services at a New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick Housing Authority-run public housing units or requesting social services from the community social service agency, "Elijah's Promise")
- Participants must be able to speak and read English.
Who cannot join
- Participants may not be taking FDA approved smoking cessation or anti-psychotic medications
- Participants may not reported medical issues of potential concern to nicotine replacement users (e.g., unstable angina pectoris, myocardial infarction, or significant cardiac arrythmia (including atrial fibrillation) in the past 30 days)
- Participants may not report pending legal issues with potential to result in incarceration.
- Participants may not be pregnant or nursing, planning on becoming pregnant in the next two months, and must be using effective birth control.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Addiction Psychiatry
New Brunswick, New Jersey, 08901
About this study
Official title: Addressing Tobacco Use Among Those At Socioeconomic Disadvantage
Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.
Read the detailed description
The investigators propose a randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers. Participants will be randomly assigned to receive a) A brief motivational interviewing intervention, b) A nicotine replacement therapy sampling intervention, or c) A referral-only intervention.
- Conditions
- Tobacco Smoking
- Being tested
- Motivational Interviewing, Nicotine Replacement Therapy Sampling, Referral Only
- Keywords
- tobacco, smoking, cigarette
- Medical subject headings
- Tobacco Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
Nicotine Replacement Therapy SamplingDrug
Also called Nicotine Replacement Therapy
Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
Referral OnlyBehavioural
Also called Referral
Participants are provided with a written referral for tobacco dependence treatment.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | 35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line Receives: Behavioral: Motivational Interviewing |
| Nicotine Replacement Therapy Sampling | Active comparator | Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line. Receives: Drug: Nicotine Replacement Therapy Sampling |
| Referral Only | Other | Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line. Receives: Behavioral: Referral Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'
A self-described "serious" attempt to quit smoking cigarettes since the initial study appointment, measured by the "Quitting Preparation and Actions Questionnaire."
Measured: 30 days
Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'
Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment
Measured: 30 days
Secondary outcomes (3)
Self-reported Cigarettes Per Day
Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm
Measured: 30 days
Importance, Confidence, & Readiness Questionnaire
Motivation and Self-efficacy for quitting smoking measured via Importance, Confidence, \& Readiness Questionnaire" (rated on a 0 to 10 scale with higher numbers indicating greater importance, confidence, or readiness to quit)
Measured: 30 days
Readiness to Quit Ladder
"Readiness to Quit Ladder" (with 10 non-numbered choices, ranging from 0 to 10 reflecting varying degrees of readiness to quit smoking; higher numbers reflect greater readiness to quit smoking)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start30 May 2018
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
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.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial in which participants are randomized to one of three groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Marc L Steinberg, Ph.D., Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620708
- Sponsor's protocol ID
- Pro20170000679
- Status last verified
- Nov 2019
- First submitted
- 29 Jun 2018
- Last updated
- 15 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Tobacco Use Among Those At Socioeconomic Disadvantage
- ClinicalTrials.gov ID
- NCT03620708
- Acronym / sponsor ID
- Pro20170000679
- Conditions
- Tobacco Smoking
- Keywords
- tobacco, smoking, cigarette
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Posted 15 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.
Detailed description
The investigators propose a randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers. Participants will be randomly assigned to receive a) A brief motivational interviewing intervention, b) A nicotine replacement therapy sampling intervention, or c) A referral-only intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized clinical trial in which participants are randomized to one of three groups.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational Interviewing35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line |
| Nicotine Replacement Therapy Sampling | Active comparator | Drug: Nicotine Replacement Therapy SamplingParticipants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line. |
| Referral Only | Other | Behavioral: Referral OnlyParticipants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be between the age of 19 and 65
- Participants must self-report being a daily smoker and provide biochemical verification of smoking status (expired breath carbon monoxide reading >5)
- Participants must be at socioeconomic disadvantage, defined as receiving services at a New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick Housing Authority-run public housing units or requesting social services from the community social service agency, "Elijah's Promise")
- Participants must be able to speak and read English.
Key exclusion criteria (4 listed)
- Participants may not be taking FDA approved smoking cessation or anti-psychotic medications
- Participants may not reported medical issues of potential concern to nicotine replacement users (e.g., unstable angina pectoris, myocardial infarction, or significant cardiac arrythmia (including atrial fibrillation) in the past 30 days)
- Participants may not report pending legal issues with potential to result in incarceration.
- Participants may not be pregnant or nursing, planning on becoming pregnant in the next two months, and must be using effective birth control.
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 |
|---|---|---|
| Motivational InterviewingParticipants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment. | Behavioural | Motivational Interviewing |
| Nicotine Replacement Therapy SamplingAlso: Nicotine Replacement TherapyParticipants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment. | Drug | Nicotine Replacement Therapy Sampling |
| Referral OnlyAlso: ReferralParticipants are provided with a written referral for tobacco dependence treatment. | Behavioural | Referral Only |
Primary outcome
Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'
Time frame: 30 days
A self-described "serious" attempt to quit smoking cigarettes since the initial study appointment, measured by the "Quitting Preparation and Actions Questionnaire."
Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'
Time frame: 30 days
Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment
3 secondary outcomes
Self-reported Cigarettes Per Day
Time frame: 30 days
Importance, Confidence, & Readiness Questionnaire
Time frame: 30 days
Readiness to Quit Ladder
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Marc L Steinberg, Ph.D. principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motivational Interviewing, Nicotine Replacement Therapy Sampling and Referral Only in people with Tobacco Smoking, run by Rutgers, The State University of New Jersey 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 4 inclusion and 4 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 15 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 15 Nov 2019). 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?
Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' (time frame: 30 days). The study lists 2 primary outcomes in all. 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 15 Nov 2019.