Smoking CessationNCT02982772
Patch Study - Intervention for HIV Positive Smokers
A study testing Combination Therapy in people with Smoking Cessation and HIV, run by dr. maria miguez at 1 site in United States.
Trial summary
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, HIV
- What is being tested?
- Combination Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 31 May 2021
- Phase
- Interventional
- 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
- HIV infected smokers
- 18 years of age and older
- Fluent in English or Spanish
- Able to consent
- Ready to quit smoking
Who cannot join
- Psychotic or disabling psychiatric disorders
- Six months post-myocardial infarction or stroke
- Diabetes requiring insulin
- Treatment for vascular problems
- Non-treated hypertension,
- Severe liver or kidney disease
Show all 11Show fewer
- History of allergies to the nicotine patches
- Severe eczema or psoriasis
- Temporal-mandibular joint disease or dental appliances
- Pregnant women or women that are breastfeeding
- Subjects participating in other interventions/research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biobehavioral Intervention for Smokers Living With HIV (Human Immunodeficiency Virus)
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. To test researchers proposed model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines + nicotine replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day.
Read the detailed description
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. This will be accomplished by assessing: 1) pre-trial plasma levels, 2) doing genotyping, which to researchers knowledge has not been used in cessation studies among people living with HIV (PLWH), and 3) providing tailored feedback to the participants, based on the assumption that the higher the knowledge and perception of risk, the higher the interest in modifying a risky behavior(s). To test researchers proposed model based in proven smoking prevention and control methods 600 PLWH ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines will consist on brief advice + nicotine replacement therapy, versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy (NRT). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day. The knowledge gained here has the potential to provide a more complete bio-behavioral model to the intervention field. The proposed study if successful will provide a new tailored, replicable, and manual-based intervention for people living with HIV. It can also provide much need it information in regards to key mediators and moderators of smoking cessation interventions in this vulnerable population. Researchers long term goal is to reduce the burden of one of the most devastating causes of morbi-mortality in researchers time and improve their quality of life. The study could also pave the path to use a similar model to tailor smoking interventions for other populations (e.g., menthol users, older women, adolescents, older adults).
- Conditions
- Smoking Cessation, HIV
- Being tested
- Combination Therapy, Standard Care Intervention
- Keywords
- Nicotine Replacement, Smoking, HIV
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination TherapyOther
Also called Nicoderm, Nicorette
Brief behavioral intervention
The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
Standard Care InterventionOther
Brief Behavioral Intervention
The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tailored Combination Therapy | Experimental | Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.
Doses will be tailored and adjust as need it Receives: Other: Combination Therapy |
| Standard Care Intervention | Active comparator | Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks. Receives: Other: Standard Care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Smoking Cessation
verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).
Measured: 3 months
Rates of Smoking Cessation
verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).
Measured: 6 months
Rates of Smoking Cessation
verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).
Measured: 12 months
Secondary outcomes (7)
Change in Clinical Outcomes
The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:
- CD4 (counts and percentage).
- HIV Viral load (logs).
- Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).
- Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].
- In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
Measured: 6 months
Number of Participants With Verified Continuous Abstinence
Verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm
Measured: 3 months
Prevalence of Side Effects-safety
Total number of self reported side effects from Baseline through 6 months.
Measured: Baseline-6 months
Change in Clinical Outcomes
The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:
- CD4 (counts and percentage).
- HIV Viral load (logs).
- Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).
- Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
- In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.
Measured: 12 months
Number of Participants With Verified Continuous Abstinence
verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm
Measured: 6 months
Number of Participants With Verified Continuous Abstinence
verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm
Measured: 12 months
Prevalence of Side Effects-safety
Total number of self reported side effects from 6 through 12 months.
Measured: 6 through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startMay 2016
- Primary completion31 May 2021
- Study completion31 May 2021
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 Smoking CessationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- dr. maria miguez
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Sponsor-investigator, dr. maria miguez, Florida International University
- Investigators
- Maria Jose Miguez, MD, Principal investigator, Florida International UniversityGuillermo Castro, MD, Study director, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982772
- Sponsor's protocol ID
- FloridaIU
- Status last verified
- Oct 2021
- First submitted
- 19 Apr 2016
- Last updated
- 6 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data will be available only after the study have 2 years of completion. The data to be shared will be de-identified and without data associated with medical records. Access will be provided upon submission of study protocol and if the IRB approves sharing the data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Intervention for Smokers Living With HIV (Human Immunodeficiency Virus)
- ClinicalTrials.gov ID
- NCT02982772
- Acronym / sponsor ID
- FloridaIU
- Conditions
- Smoking Cessation, HIV
- Keywords
- Nicotine Replacement, Smoking, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- dr. maria miguezUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- May 2016
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 22 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. To test researchers proposed model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines + nicotine replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day.
Detailed description
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. This will be accomplished by assessing: 1) pre-trial plasma levels, 2) doing genotyping, which to researchers knowledge has not been used in cessation studies among people living with HIV (PLWH), and 3) providing tailored feedback to the participants, based on the assumption that the higher the knowledge and perception of risk, the higher the interest in modifying a risky behavior(s). To test researchers proposed model based in proven smoking prevention and control methods 600 PLWH ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines will consist on brief advice + nicotine replacement therapy, versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy (NRT). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day. The knowledge gained here has the potential to provide a more complete bio-behavioral model to the intervention field. The proposed study if successful will provide a new tailored, replicable, and manual-based intervention for people living with HIV. It can also provide much need it information in regards to key mediators and moderators of smoking cessation interventions in this vulnerable population. Researchers long term goal is to reduce the burden of one of the most devastating causes of morbi-mortality in researchers time and improve their quality of life. The study could also pave the path to use a similar model to tailor smoking interventions for other populations (e.g., menthol users, older women, adolescents, older adults).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Combination Therapy | Experimental | Other: Combination TherapyCombination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjust as need it |
| Standard Care Intervention | Active comparator | Other: Standard Care InterventionBrief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used. Standard Flavored gums will be used as needed for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infected smokers
- 18 years of age and older
- Fluent in English or Spanish
- Able to consent
- Ready to quit smoking
Key exclusion criteria (11 listed)
- Psychotic or disabling psychiatric disorders
- Six months post-myocardial infarction or stroke
- Diabetes requiring insulin
- Treatment for vascular problems
- Non-treated hypertension,
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 |
|---|---|---|
| Combination TherapyAlso: Nicoderm, NicoretteBrief behavioral intervention The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks. | Other | Tailored Combination Therapy |
| Standard Care InterventionBrief Behavioral Intervention The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used. Standard Flavored Gums for 10 weeks | Other | Standard Care Intervention |
Primary outcome
Rates of Smoking Cessation
Time frame: 3 months
verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).
Rates of Smoking Cessation
Time frame: 6 months
verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).
Rates of Smoking Cessation
Time frame: 12 months
verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).
7 secondary outcomes
Change in Clinical Outcomes
Time frame: 6 months
Number of Participants With Verified Continuous Abstinence
Time frame: 3 months
Prevalence of Side Effects-safety
Time frame: Baseline-6 months
Change in Clinical Outcomes
Time frame: 12 months
Number of Participants With Verified Continuous Abstinence
Time frame: 6 months
Number of Participants With Verified Continuous Abstinence
Time frame: 12 months
Prevalence of Side Effects-safety
Time frame: 6 through 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The data will be available only after the study have 2 years of completion. The data to be shared will be de-identified and without data associated with medical records. Access will be provided upon submission of study protocol and if the IRB approves sharing the data.
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
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.
Maria Jose Miguez, MD principal investigator
Florida International University
Guillermo Castro, MD study director
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination Therapy in people with Smoking Cessation and HIV, run by dr. maria miguez 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 5 inclusion and 11 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 Oct 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2021). 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?
Rates of Smoking Cessation (time frame: 3 months). The study lists 3 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 6 Oct 2021.