SmokingNCT03308331
HIV-1 and Brain Interaction on Smoking Comorbidity
A study testing Tobacco smoking and nicotine patch in people with Smoking, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
People living with HIV-1 have high rates of cigarette smoking, which may be related to nicotinic interaction with HIV-1 infection and brain function levels. The proposed project aims to understand these pathways using translational brain imaging and HIV-1 reactivation studies. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Tobacco smoking 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 Dec 2019to 30 Oct 2025
- Phase
- Interventional
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects between ages 18-60 in good health
- Ability to give written informed consent
- For people living with HIV: should be diagnosed with HIV two years or more and on ART two years or more
- For people living with HIV: should have achieved virologic suppression (defined as viral loads of ≤ 200 copies/ml), and without current signs of reactivation
Who cannot join
- Inability to sign informed consent
- Unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobic to the scanner
- Any major medical illnesses to include, but not limited to, uncontrolled high blood pressure or high blood sugar, cardiovascular disease, asthma, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis as per medical history
- Current substance-induced psychiatric disorders
- Significant alcohol or other drug use, other than nicotine dependence or marijuana use
- Gross structural abnormalities and/or have a history of syncope
Show all 10Show fewer
- Positive urine pregnancy tests
- Any neurological illnesses to include, but not limited to, seizure disorders, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor,
- For people living with HIV: having AIDS or non-AIDS-defining cancer or active CNS and other opportunistic disease
- For people living with HIV: on active treatment of hepatitis C virus (HCV)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine
Baltimore, Maryland, 21228
About this study
People living with HIV-1 have high rates of cigarette smoking, which may be related to nicotinic interaction with HIV-1 infection and brain function levels. The proposed project aims to understand these pathways using translational brain imaging and HIV-1 reactivation studies. The study proposes a targeted nicotine-brain investigation of the nicotinic effects in HIV-1 infection from cellular to brain circuitry levels.
Read the detailed description
Smoking remains the leading cause of preventable morbidity and mortality in the United States. The alarmingly high smoking rates and unsatisfactory performance of standard smoking cessation efforts in people living with HIV/AIDS (PLWH) interfere with the overall progress in the treatment of HIV-1 infection. Our understanding of nicotine addiction mechanisms in PLWH, and how they are related to and interact with HIV-1 neuropathology, is limited and thus hindering the development of more effective, targeted treatments. The study will directly address neurological complication of this HIV-associated comorbidity at the brain circuitry level using state-of-the-art imaging tools and methods.
- Conditions
- Smoking
- Being tested
- Tobacco smoking and nicotine patch
- Keywords
- HIV, nicotine, brain, smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco smoking and nicotine patchOther
Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 smokers | Experimental | Not described Receives: Other: Tobacco smoking and nicotine patch |
| HIV-1 nonsmokers | No intervention | Not described |
| Healthy control smokers | Active comparator | Not described Receives: Other: Tobacco smoking and nicotine patch |
| Healthy control nonsmokers | No intervention | Not described |
| HIV-1 nonsmokers using nicotine patch | Active comparator | Not described Receives: Other: Tobacco smoking and nicotine patch |
| HIV-1 nonsmokers using placebo patch | No intervention | Not described |
| Healthy control nonsmokers using nicotine patch | Active comparator | Not described Receives: Other: Tobacco smoking and nicotine patch |
| Healthy control nonsmokers using placebo patch | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and structural connectivity using magnetic resonance imaging (MRI)
Resting functional MRI and diffusion imaging MRI
Measured: one day
Secondary outcomes (1)
HIV-1 reactivation
HIV-1 viral protein p24 expression
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 Dec 2019 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Why it stopped: We originally had a collaboration with a PI but he has left the University.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L. Elliot Hong, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308331
- Sponsor's protocol ID
- HP-00075780
- Status last verified
- Mar 2020
- First submitted
- 7 Oct 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-1 and Brain Interaction on Smoking Comorbidity
- ClinicalTrials.gov ID
- NCT03308331
- Acronym / sponsor ID
- HP-00075780
- Conditions
- Smoking
- Keywords
- HIV, nicotine, brain, smoking
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We originally had a collaboration with a PI but he has left the University.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 12 Oct 2017 (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.
People living with HIV-1 have high rates of cigarette smoking, which may be related to nicotinic interaction with HIV-1 infection and brain function levels. The proposed project aims to understand these pathways using translational brain imaging and HIV-1 reactivation studies. The study proposes a targeted nicotine-brain investigation of the nicotinic effects in HIV-1 infection from cellular to brain circuitry levels.
Detailed description
Smoking remains the leading cause of preventable morbidity and mortality in the United States. The alarmingly high smoking rates and unsatisfactory performance of standard smoking cessation efforts in people living with HIV/AIDS (PLWH) interfere with the overall progress in the treatment of HIV-1 infection. Our understanding of nicotine addiction mechanisms in PLWH, and how they are related to and interact with HIV-1 neuropathology, is limited and thus hindering the development of more effective, targeted treatments. The study will directly address neurological complication of this HIV-associated comorbidity at the brain circuitry level using state-of-the-art imaging tools and methods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HIV-1 smokers | Experimental | Other: Tobacco smoking and nicotine patch |
| HIV-1 nonsmokers | No intervention | – |
| Healthy control smokers | Active comparator | Other: Tobacco smoking and nicotine patch |
| Healthy control nonsmokers | No intervention | – |
| HIV-1 nonsmokers using nicotine patch | Active comparator | Other: Tobacco smoking and nicotine patch |
| HIV-1 nonsmokers using placebo patch | No intervention | – |
| Healthy control nonsmokers using nicotine patch | Active comparator | Other: Tobacco smoking and nicotine patch |
| Healthy control nonsmokers using placebo patch | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects between ages 18-60 in good health
- Ability to give written informed consent
- For people living with HIV: should be diagnosed with HIV two years or more and on ART two years or more
- For people living with HIV: should have achieved virologic suppression (defined as viral loads of ≤ 200 copies/ml), and without current signs of reactivation
Key exclusion criteria (10 listed)
- Inability to sign informed consent
- Unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobic to the scanner
- Any major medical illnesses to include, but not limited to, uncontrolled high blood pressure or high blood sugar, cardiovascular disease, asthma, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis as per medical history
- Current substance-induced psychiatric disorders
- Significant alcohol or other drug use, other than nicotine dependence or marijuana use
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 |
|---|---|---|
| Tobacco smoking and nicotine patchTobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use | Other | HIV-1 nonsmokers using nicotine patch, HIV-1 smokers, Healthy control nonsmokers using nicotine patch, Healthy control smokers |
Primary outcome
Functional and structural connectivity using magnetic resonance imaging (MRI)
Time frame: one day
Resting functional MRI and diffusion imaging MRI
1 secondary outcome
HIV-1 reactivation
Time frame: one day
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 10 Mar 2020.
Related trials for Smoking
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Recruiting
Feasibility and Uptake of Low-Dose CT Lung Cancer Screening in Kuwait
Lung Cancer, Lung Neoplasms
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco smoking and nicotine patch in people with Smoking, run by University of Maryland, Baltimore 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 10 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 10 Mar 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.
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?
Functional and structural connectivity using magnetic resonance imaging (MRI) (time frame: one day). 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 10 Mar 2020.