Tobacco Use CessationEarly Phase 1NCT05060965
Inpatient Smoking Cessation Pilot Program
A Early Phase 1 study testing Nicotine lozenge, Nicotine gum and Nicotine patch in people with Tobacco Use Cessation, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators are implementing a stepwise approach to cessation with a public health focus to improve health outcomes for the investigators' pediatric patients. The investigators are focusing on addressing caregiver smoking as a modifiable risk factor during time of child's hospitalization as a window of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Nicotine lozenge, Nicotine gum and Nicotine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to Apr 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregivers of patients on an inpatient unit at Johns Hopkins Children's Center who self-identify as tobacco users and wish to initiate tobacco cessation
Who cannot join
- Pregnant or breast feeding maternal caregivers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoking Cessation Pilot Program on 9 South
The investigators are implementing a stepwise approach to cessation with a public health focus to improve health outcomes for the investigators' pediatric patients. The investigators are focusing on addressing caregiver smoking as a modifiable risk factor during time of child's hospitalization as a window of opportunity to provide counseling and education to families on secondhand and third hand smoke exposure as well as information on NRT products to heighten caregiver contemplation for quitting. One of the central goals of the investigators' project is to increase immediate access to Nicotine Replacement Therapy (NRT) resources for families during hospitalization which pediatric providers could potentially dose and prescribe to caregivers who are screened positive for smoking. Long-term cessation care is provided by referrals to both the MD Quitline and the John Hopkins Tobacco Treatment Clinic. Both are provided to allow participants options that the participants would find preferable from an insurance and provider perspective.
- Conditions
- Tobacco Use Cessation
- Being tested
- Nicotine lozenge, Nicotine gum, Nicotine patch, Maryland Quitline, John Hopkins Tobacco Treatment Clinic
- 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 lozengeDrug
Nicotine replacement therapy
Nicotine gumDrug
Nicotine replacement therapy
Nicotine patchDrug
Nicotine replacement therapy
Maryland QuitlineOther
Telephone-based tobacco cessation service
John Hopkins Tobacco Treatment ClinicOther
Clinic-based tobacco cessation service
| Study group | Role | What they receive |
|---|---|---|
| Cessation intervention | Experimental | All participants will receive nicotine replacement therapy and a referral to both Maryland Quitline and Johns Hopkins Tobacco Treatment Clinic for continued cessation care.
Nicotine replacement therapy: Nicoderm patches, gum, lozenges
* Low nicotine dependence: Lozenge (2 mg) or Gum (2 mg) or Patch (7 mg)
* Moderate nicotine dependence: Patch (14 mg) and Lozenge (2 mg) or Gum (2 mg)
* High nicotine dependence: Patch (21 mg) and Lozenge (4 mg) or Gum (4 mg)
Regardless of the level of nicotine addiction and subsequent dose of nicotine replacement therapy (NRT), participants of this trials are described as "recipients of NRT products". Receives: Drug: Nicotine lozenge; Drug: Nicotine gum; Drug: Nicotine patch; Other: Maryland Quitline; Other: John Hopkins Tobacco Treatment Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-reported attempts to quit smoking
Change in caregiver self-reported tobacco cessation attempt in the past 14-days.
Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Secondary outcomes (2)
Change in Frequency of usage of outpatient tobacco cessation services
Change in frequency of caregiver self-reported usage of outpatient tobacco cessation services (Maryland Quitline or Johns Hopkins Tobacco Treatment Clinic).
Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Change in Usage of nicotine replacement therapy products
Change in caregiver self-reported usage of nicotine replacement therapy in the past 14-days.
Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Oct 2019
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: No Enrollees
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mandeep S. Jassal, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060965
- Sponsor's protocol ID
- IRB00208192
- Status last verified
- Aug 2023
- First submitted
- 20 Sep 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified participant data will be shared with researchers or sponsor upon review of a written request. The request will require a detailed description of the usage of the data and will require approval by the principal investigator. A data use agreement will be set-up and a plan for data removal (including timeline) will be established.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Pilot Program on 9 South
- ClinicalTrials.gov ID
- NCT05060965
- Acronym / sponsor ID
- IRB00208192
- Conditions
- Tobacco Use Cessation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Enrollees
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are implementing a stepwise approach to cessation with a public health focus to improve health outcomes for the investigators' pediatric patients. The investigators are focusing on addressing caregiver smoking as a modifiable risk factor during time of child's hospitalization as a window of opportunity to provide counseling and education to families on secondhand and third hand smoke exposure as well as information on NRT products to heighten caregiver contemplation for quitting. One of the central goals of the investigators' project is to increase immediate access to Nicotine Replacement Therapy (NRT) resources for families during hospitalization which pediatric providers could potentially dose and prescribe to caregivers who are screened positive for smoking. Long-term cessation care is provided by referrals to both the MD Quitline and the John Hopkins Tobacco Treatment Clinic. Both are provided to allow participants options that the participants would find preferable from an insurance and provider perspective.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cessation intervention | Experimental | Drug: Nicotine lozenge, Drug: Nicotine gum, Drug: Nicotine patch, Other: Maryland Quitline, Other: John Hopkins Tobacco Treatment ClinicAll participants will receive nicotine replacement therapy and a referral to both Maryland Quitline and Johns Hopkins Tobacco Treatment Clinic for continued cessation care. Nicotine replacement therapy: Nicoderm patches, gum, lozenges * Low nicotine dependence: Lozenge (2 mg) or Gum (2 mg) or Patch (7 mg) * Moderate nicotine dependence: Patch (14 mg) and Lozenge (2 mg) or Gum (2 mg) * High nicotine dependence: Patch (21 mg) and Lozenge (4 mg) or Gum (4 mg) Regardless of the level of nicotine addiction and subsequent dose of nicotine replacement therapy (NRT), participants of this trials are described as "recipients of NRT products". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caregivers of patients on an inpatient unit at Johns Hopkins Children's Center who self-identify as tobacco users and wish to initiate tobacco cessation
Key exclusion criteria (1 listed)
- Pregnant or breast feeding maternal caregivers.
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 |
|---|---|---|
| Nicotine lozengeNicotine replacement therapy | Drug | Cessation intervention |
| Nicotine gumNicotine replacement therapy | Drug | Cessation intervention |
| Nicotine patchNicotine replacement therapy | Drug | Cessation intervention |
| Maryland QuitlineTelephone-based tobacco cessation service | Other | Cessation intervention |
| John Hopkins Tobacco Treatment ClinicClinic-based tobacco cessation service | Other | Cessation intervention |
Primary outcome
Change in Self-reported attempts to quit smoking
Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Change in caregiver self-reported tobacco cessation attempt in the past 14-days.
2 secondary outcomes
Change in Frequency of usage of outpatient tobacco cessation services
Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Change in Usage of nicotine replacement therapy products
Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: No. De-identified participant data will be shared with researchers or sponsor upon review of a written request. The request will require a detailed description of the usage of the data and will require approval by the principal investigator. A data use agreement will be set-up and a plan for data removal (including timeline) will be established.
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THE EFFECT OF A TRANSTHEORETICAL MODEL-BASED CHATBOT SUPPORT INTERVENTION ON SMOKING BEHAVIOR IN UNIVERSITY STUDENTS
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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.
Mandeep S. Jassal, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nicotine lozenge, Nicotine gum and Nicotine patch in people with Tobacco Use Cessation, run by Johns Hopkins University 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 15 Aug 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Self-reported attempts to quit smoking (time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months). 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 Aug 2023.