Tobacco Use CessationPhase 2/3NCT04994444
Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts
A Phase 2/3 study testing Nicoderm CQ 21Mg/24Hr Transdermal System in people with Tobacco Use Cessation, run by Brown University at 1 site in United States.
Trial summary
The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking… 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?
- Nicoderm CQ 21Mg/24Hr Transdermal System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Apr 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with HIV
- at least 18 years of age
- smoking at least 5 cigarettes/day
- exhaled Carbon Monoxide level greater than 5 at baseline
- willing to use transdermal nicotine patch
- ready to quit in the next 30 days.
Who cannot join
- currently using pharmacotherapy for smoking cessation
- medically or psychiatrically unstable (defined as: uncontrolled hypertension, unstable angina, or a medical or psychiatric hospitalization in the 30 days prior to enrollment) *experiencing psychotic symptoms
- endorsing suicidal ideation upon screening or past-year suicide attempt
- pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 16-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge (or gum, based on preference) on quit date (week 4), consistent with recommended guidelines based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge (or gum, based on preference), initiated on quit date. The investigators will examine dependence, urge to smoke and self-efficacy for quitting prior to and following quit date. The investigators will also examine differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8, 12, and 16.
Read the detailed description
Cigarette smoking is more prevalent in persons with HIV (PWH) in the U.S. when compared with the general population and is linked to increased morbidity and mortality in this population. Furthermore, HIV-positive smokers have increased rates of lung and other smoking-related cancers. Smokers with HIV are a particularly challenging group, often reporting high severity of nicotine dependence and low rates of self-efficacy for quitting, both factors related to poor smoking cessation outcomes. Establishing more effective smoking cessation approaches for smokers with HIV, particularly those that address low self-efficacy and severe dependence, is a public health priority. The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 12-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge on quit date (week 4), consistent with recommended guideline based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge, initiated on quit date. Dependence, urge to smoke and self-efficacy for quitting prior to and following quit date will be examined. Differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8 and 12 will also be examined. This study will be the first to examine the feasibility and initial efficacy of a novel intervention using NRT preloading to improve smoking cessation outcomes in PWH. Given the high prevalence of smoking and the significant morbidity associated with it in PWH, the development of effective strategies to reduce the risks related to smoking in this group is critical. If determined to be effective, this intervention could be readily disseminated in HIV clinics. This study will provide key information on the potential benefit of NRT preloading in a population that is highly dependent on nicotine and highly vulnerable to smoking-related morbidity and mortality.
- Conditions
- Tobacco Use Cessation
- Being tested
- Nicoderm CQ 21Mg/24Hr Transdermal System
- Keywords
- smoking, HIV, Cessation
- Medical subject headings
- Tobacco Use Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicoderm CQ 21Mg/24Hr Transdermal SystemDrug
Also called Nicotine replacement therapy
Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
| Study group | Role | What they receive |
|---|---|---|
| Preloading | Experimental | Participants will be started on nicotine patch 3 weeks prior to quit date. At quit date they will use patch and lozenge or gum for 8 weeks. Receives: Drug: Nicoderm CQ 21Mg/24Hr Transdermal System |
| Standard treatment | Active comparator | Participants will start combination nicotine replacement therapy (patch/gum or patch/lozenge) on their assigned quit date. NRT will be provided for 8 weeks. Receives: Drug: Nicoderm CQ 21Mg/24Hr Transdermal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to NRT
Number of days of nicotine patch use during the 8 weeks of provision
Measured: week 12
Secondary outcomes (1)
7 Day Point Prevalence Abstinence
number of participants who reported no cigarette smoking in past 7 days
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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 Use CessationStudies of the same condition, open and under way.
- More trials run by Brown 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patricia Cioe, PhD, Principal investigator, Brown University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994444
- Sponsor's protocol ID
- 2102002917
- Other IDs
- 1R21CA261233-01
- Status last verified
- Mar 2025
- First submitted
- 29 Jul 2021
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The proposed research will include data from 60 subjects being enrolled into a pilot randomized clinical trial where participants who smoke combustible cigarettes will be randomized to one of two conditions: the nicotine replacement therapy preloading condition (NRT-P), or the standard treatment condition (ST). The final dataset will include self-reported demographic and behavioral data from interviews with the subjects. The final dataset will be stripped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts
- ClinicalTrials.gov ID
- NCT04994444
- Acronym / sponsor ID
- 2102002917
- Conditions
- Tobacco Use Cessation
- Keywords
- smoking, HIV, Cessation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Posted 6 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 16-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge (or gum, based on preference) on quit date (week 4), consistent with recommended guidelines based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge (or gum, based on preference), initiated on quit date. The investigators will examine dependence, urge to smoke and self-efficacy for quitting prior to and following quit date. The investigators will also examine differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8, 12, and 16.
Detailed description
Cigarette smoking is more prevalent in persons with HIV (PWH) in the U.S. when compared with the general population and is linked to increased morbidity and mortality in this population. Furthermore, HIV-positive smokers have increased rates of lung and other smoking-related cancers. Smokers with HIV are a particularly challenging group, often reporting high severity of nicotine dependence and low rates of self-efficacy for quitting, both factors related to poor smoking cessation outcomes. Establishing more effective smoking cessation approaches for smokers with HIV, particularly those that address low self-efficacy and severe dependence, is a public health priority. The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 12-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge on quit date (week 4), consistent with recommended guideline based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge, initiated on quit date. Dependence, urge to smoke and self-efficacy for quitting prior to and following quit date will be examined. Differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8 and 12 will also be examined. This study will be the first to examine the feasibility and initial efficacy of a novel intervention using NRT preloading to improve smoking cessation outcomes in PWH. Given the high prevalence of smoking and the significant morbidity associated with it in PWH, the development of effective strategies to reduce the risks related to smoking in this group is critical. If determined to be effective, this intervention could be readily disseminated in HIV clinics. This study will provide key information on the potential benefit of NRT preloading in a population that is highly dependent on nicotine and highly vulnerable to smoking-related morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Preloading | Experimental | Drug: Nicoderm CQ 21Mg/24Hr Transdermal SystemParticipants will be started on nicotine patch 3 weeks prior to quit date. At quit date they will use patch and lozenge or gum for 8 weeks. |
| Standard treatment | Active comparator | Drug: Nicoderm CQ 21Mg/24Hr Transdermal SystemParticipants will start combination nicotine replacement therapy (patch/gum or patch/lozenge) on their assigned quit date. NRT will be provided for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed with HIV
- at least 18 years of age
- smoking at least 5 cigarettes/day
- exhaled Carbon Monoxide level greater than 5 at baseline
- willing to use transdermal nicotine patch
Key exclusion criteria (4 listed)
- currently using pharmacotherapy for smoking cessation
- medically or psychiatrically unstable (defined as: uncontrolled hypertension, unstable angina, or a medical or psychiatric hospitalization in the 30 days prior to enrollment) *experiencing psychotic symptoms
- endorsing suicidal ideation upon screening or past-year suicide attempt
- pregnant or nursing.
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 |
|---|---|---|
| Nicoderm CQ 21Mg/24Hr Transdermal SystemAlso: Nicotine replacement therapyNicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period. | Drug | Preloading, Standard treatment |
Primary outcome
Adherence to NRT
Time frame: week 12
Number of days of nicotine patch use during the 8 weeks of provision
1 secondary outcome
7 Day Point Prevalence Abstinence
Time frame: week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The proposed research will include data from 60 subjects being enrolled into a pilot randomized clinical trial where participants who smoke combustible cigarettes will be randomized to one of two conditions: the nicotine replacement therapy preloading condition (NRT-P), or the standard treatment condition (ST). The final dataset will include self-reported demographic and behavioral data from interviews with the subjects. The final dataset will be stripped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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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.
Patricia Cioe, PhD principal investigator
Brown University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nicoderm CQ 21Mg/24Hr Transdermal System in people with Tobacco Use Cessation, run by Brown 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 6 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 6 Apr 2025. 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 6 Apr 2025). 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?
Adherence to NRT (time frame: week 12). 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 6 Apr 2025.