SmokingPhase 3NCT02460900

Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke

A Phase 3 study testing Varenicline and Positively Smoke Free in people with Smoking and HIV, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Smoking, HIV
What is being tested?: Varenicline and Positively Smoke Free
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 184 participants
Where: 1 siteUnited States
Study dates: Jul 2016to Apr 2021
Phase: Phase 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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study Inclusion Criteria:

Confirmed chart diagnosis of a HIV and receiving HIV treatment at the participating HIV clinic.
Age 18 years or older.
Currently self-report smoking 10 cigarettes per day
Motivation to quit within the next 6 months (score 5-8 on the Abrams and Briener Readiness to Quit Ladder);
Does not meet criteria for current Diagnostic Statistical Manual (DSM) 5 moderate or severe alcohol use disorder or moderate or severe substance use disorder as established by the Mini Neuropsychiatric Interview (MINI) drug and alcohol sections (in the last 3 months)
Able to read and speak English
Willingness and ability to provide informed consent to participate.

Study Exclusion Criteria:

The exclusion criteria are designed to maximize safety by minimizing drug interactions or worsening pre-existing comorbid psychiatric or medical conditions:

Current suicidal thoughts or ideation (past week); recent suicidal thoughts or ideation (past 6 months) or recent suicide attempt (past 6 months) as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
Previous allergic reaction or hypersensitivity to Varenicline (by participant report ever in lifetime)
Pregnant, nursing, or becoming pregnant during the study (pregnancy test).
Current use of any medication that would interfere with the protocol in the opinion of Medically Accountable Physician including use of bupropion targeting nicotine dependence
Moderate to severe renal impairment (< 30 mL/min)--As determined by a physician assessment, chart review or thru blood work
Unstable cardiovascular disease (myocardial infarction within past year, uncontrolled arrhythmia, uncontrolled angina, uncontrolled congestive heart failure, electrocardiogram abnormality with QTC > 500 msec, cerebrovascular event within past year). (As determined by a physician assessment, chart review and/or EKG)
Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale. This criterion is included to ensure the sample consists of participants who are cognitively able to engage in the study procedures
Scores <5 ppm of expired carbon monoxide (CO) on the Smokelyzer
The study physician believes that the individual is not medially stable enough to participate in the study. This exclusion will be based on a review of the individual's past medical history and current medical status.
Recent use of Varenicline (by participant report in the past 3 months)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland Medical Center, Midtown Campus
Baltimore, Maryland, 21210

Other trials in United States

About this study

The single greatest health behavior change that could improve cardiovascular morbidity and associated mortality is to assist people living with HIV/AIDS who smoke to quit. The investigators will use a factorial design to evaluate the most promising behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV/AIDS who smoke. Results of this study will provide crucial, real world evidence of the best way for healthcare providers to help smokers living with HIV/AIDS quit smoking.

Read the detailed description

The study used a factorial design to randomize participants into 4 conditions: (1) Varenicline (12 weeks) + Positively Smoke Free (PSF) (8 weeks); (2) Varenicline (12 weeks) + Standard of Care (brief advice to quit); (3) Placebo (12 weeks) + Positively Smoke Free (8 weeks); and (4) Placebo (12 weeks) + Standard of Care. The primary outcome was the 7-day point prevalence abstinence (PPA) (<10mm) at 36 weeks.

The specific aims of our proposal are:

Primary Aim 1: Compare varenicline to placebo on rates of 7-day point prevalence abstinence (PPA) at 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with varenicline compared to placebo.

Primary Aim 2: Compare Positively Smoke Free to low intensity, brief counseling on rates of 7-day PPA at 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with Positively Smoke Free compared to brief counseling.

Primary Aim 3: Compare Positively Smoke Free + varenicline to the other two study conditions outlined above on rates of 7-day PPA in smokers with HIV/AIDS at 36 weeks. We hypothesize the effect of PSF with varenicline is greater than the effect of PSF or varenicline alone.

Exporatory Aim: Explore the effect of successful cessation/smoking abstinence on levels of cardiac specific biomarkers, nicotine biomarkers, generalized markers of inflammation, lipids, coagulation and monocyte/macrophage activation.

Conditions: Smoking, HIV
Being tested: Varenicline, Positively Smoke Free, Placebo, Standard of Care
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VareniclineDrug
Positively Smoke FreeBehavioural
PlaceboDrug
Standard of CareBehavioural

Study groups in NCT02460900
Study group	Role	What they receive
Varenicline and Standard of Care	Active comparator	Participants will receive varenicline and standard of care Receives: Drug: Varenicline; Behavioral: Standard of Care
Placebo and Standard of Care	Placebo comparator	Participants will receive placebo and standard of care Receives: Drug: Placebo; Behavioral: Standard of Care
Positively Smoke Free and Placebo	Active comparator	Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Placebo Receives: Behavioral: Positively Smoke Free; Drug: Placebo
Positively Smoke Free and Varenicline	Active comparator	Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Varenicline Receives: Drug: Varenicline; Behavioral: Positively Smoke Free

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks
7-day point-prevalence abstinence based onno self-reported tobacco use (not even a puff) during the 7 days preceding the assessment and a CO ≤10ppm as measured by Covita micro smokrlyzer at week 36.
Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Apr 2021

First posted3 Jun 2015 (estimated)
Study startJul 2016
Primary completionApr 2021
Study completionApr 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02460900
Sponsor's protocol ID: HP-00062925
Other IDs: R01HL136253
Status last verified: Feb 2025
First submitted: 29 May 2015
Last updated: 13 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Omanya AA, Shuter J, Koech E, Ojoo S, Potts W, Li L, Kahler CW, Himelhoch SS. Mediation Effects of Biobehavioral Factors in a Trial of Pharmacotherapy and Intensive Cessation Counseling for People with HIV Who Smoke Cigarettes in Nairobi, Kenya. AIDS Behav. 2026 May;30(5):1498-1505. doi: 10.1007/s10461-025-04968-5. Epub 2025 Dec 10.
PubMed 41369963

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke
ClinicalTrials.gov ID: NCT02460900
Acronym / sponsor ID: HP-00062925
Conditions: Smoking, HIV
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jul 2016 (actual)
Primary completion: Apr 2021 (actual)
Study completion: Apr 2021 (actual)
First posted: 3 Jun 2015 (estimated)
Results: Posted 7 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The specific aims of our proposal are:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Varenicline and Standard of Care	Active comparator	Drug: Varenicline, Behavioral: Standard of CareParticipants will receive varenicline and standard of care
Placebo and Standard of Care	Placebo comparator	Drug: Placebo, Behavioral: Standard of CareParticipants will receive placebo and standard of care
Positively Smoke Free and Placebo	Active comparator	Behavioral: Positively Smoke Free, Drug: PlaceboParticipant will receive Positively Smoke Free (a tailored behavioral intervention) and Placebo
Positively Smoke Free and Varenicline	Active comparator	Drug: Varenicline, Behavioral: Positively Smoke FreeParticipant will receive Positively Smoke Free (a tailored behavioral intervention) and Varenicline

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Varenicline	Drug	Positively Smoke Free and Varenicline, Varenicline and Standard of Care
Positively Smoke Free	Behavioural	Positively Smoke Free and Placebo, Positively Smoke Free and Varenicline
Placebo	Drug	Placebo and Standard of Care, Positively Smoke Free and Placebo
Standard of Care	Behavioural	Placebo and Standard of Care, Varenicline and Standard of Care

Primary outcome

Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks
Time frame: 36 weeks
7-day point-prevalence abstinence based onno self-reported tobacco use (not even a puff) during the 7 days preceding the assessment and a CO ≤10ppm as measured by Covita micro smokrlyzer at week 36.

Results and safety

Results posted to the registry on 7 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline and Standard of Care	46	36
Placebo and Standard of Care	47	37
Positively Smoke Free and Placebo	42	28
Positively Smoke Free and Varenicline	49	30

Primary outcome: Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks

Time frame: 36 weeks. Count of participants. Unit: Participants

Measure	Varenicline and Standard of Care n = 46	Placebo and Standard of Care n = 47	Positively Smoke Free and Placebo n = 42	Positively Smoke Free and Varenicline n = 49
Value	5	4	1	5

Adverse events

Time frame: 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline + Standard of Care	0 of 46 (0%)	33 of 46 (71.7%)	0 of 46
Placebo + Standard of Care	0 of 47 (0%)	30 of 47 (63.8%)	0 of 47
Positively Smoke Free + Placebo	0 of 42 (0%)	25 of 42 (59.5%)	0 of 42
Positively Smoke Free + Varenicline	0 of 49 (0%)	32 of 49 (65.3%)	0 of 49

Limitations and caveats (from the sponsor): From March 16, 2020-August 10, 2020 study recruitment was halted due to COVID-19.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41369963Omanya AA, Shuter J, Koech E, Ojoo S, Potts W, Li L, Kahler CW, Himelhoch SS. Mediation Effects of Biobehavioral Factors in a Trial of Pharmacotherapy and Intensive Cessation Counseling for People with HIV Who Smoke Cigarettes in Nairobi, Kenya. AIDS Behav. 2026 May;30(5):1498-1505. doi: 10.1007/s10461-025-04968-5. Epub 2025 Dec 10.

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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.

Seth Himelhoch, MD, MPH principal investigator

University of Maryland, Baltimore

Deanna Kelly, PharmD principal investigator

University of Maryland, Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Varenicline and Positively Smoke Free in people with Smoking and HIV, 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?

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 13 Mar 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. Some participants in this study may receive a placebo. 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 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 7 Mar 2023). 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?

Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02460900, which also lists 1 linked publication.

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 13 Mar 2025.