SmokingNCT00701896
Smoking Cessation Using Motivational Therapy and Varenicline
A study testing Varenicline tartrate, Nicotine Replacement Therapy and Motivational Interview in people with Smoking and HIV Infections, run by Philip Diaz at 1 site in United States.
Trial summary
People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, HIV Infections
- What is being tested?
- Varenicline tartrate, Nicotine Replacement Therapy and Motivational Interview
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2008to 20 Jun 2013
- 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
- 18 years of age and older;
- diagnosis of HIV;
- self-reported smoking on a daily basis;
- provide informed written consent
Who cannot join
- persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)
- unable to understand spoken English
- age less than 18 years.
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.
Read the detailed description
HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.
- Conditions
- Smoking, HIV Infections
- Being tested
- Varenicline tartrate, Nicotine Replacement Therapy, Biological Control, Motivational Interview
- Keywords
- HIV, Positive, Smokers, Varenicline
- Medical subject headings
- Smoking, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline tartrateDrug
Also called Chantix
1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.
Nicotine Replacement TherapyDrug
Nicotine gum and nicotine patch
Biological ControlOther
No treatment intervention only information and procedures.
Motivational InterviewBehavioural
60 minute one-on-one Interview
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control - Non-smoking | Other | Healthy Control arm with 51 subjects who are HIV negative and do not smoke Receives: Other: Biological Control |
| Healthy Control - Smoker | Other | Healthy Control arm, includes 50 subjects who are HIV negative and are smokers. Receives: Other: Biological Control |
| HIV Smoking Cessation Arm | Active comparator | Includes up to 365 subjects who are HIV positive and initiate smoking cessation Receives: Drug: Varenicline tartrate; Drug: Nicotine Replacement Therapy |
| Motivational Intervention | Experimental | Includes up to 100 subjects who are HIV positive, do not wish to quit smoking but are willing to undergo one-on-one Motivational Intervention Receives: Behavioral: Motivational Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Safety of Varenicline in PLWH Who Smoke
To determine the safety and tolerability of varenicline compared to nicotine replacement
Measured: 3 months
Secondary outcomes (1)
To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study start3 Oct 2008
- Primary completion20 Apr 2013
- Study completion20 Jun 2013
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Diaz
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Philip Diaz, Ohio State University
- Investigators
- Philip T. Diaz, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701896
- Sponsor's protocol ID
- 2007H0173
- Other IDs
- R01HL090313
- Status last verified
- Dec 2020
- First submitted
- 17 Jun 2008
- Last updated
- 15 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation and the Natural History of HIV-Associated Emphysema
- ClinicalTrials.gov ID
- NCT00701896
- Acronym / sponsor ID
- 2007H0173
- Conditions
- Smoking, HIV Infections
- Keywords
- HIV, Positive, Smokers, Varenicline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Philip DiazUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Oct 2008 (actual)
- Primary completion
- 20 Apr 2013 (actual)
- Study completion
- 20 Jun 2013 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 15 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.
Detailed description
HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Control - Non-smoking | Other | Other: Biological ControlHealthy Control arm with 51 subjects who are HIV negative and do not smoke |
| Healthy Control - Smoker | Other | Other: Biological ControlHealthy Control arm, includes 50 subjects who are HIV negative and are smokers. |
| HIV Smoking Cessation Arm | Active comparator | Drug: Varenicline tartrate, Drug: Nicotine Replacement TherapyIncludes up to 365 subjects who are HIV positive and initiate smoking cessation |
| Motivational Intervention | Experimental | Behavioral: Motivational InterviewIncludes up to 100 subjects who are HIV positive, do not wish to quit smoking but are willing to undergo one-on-one Motivational Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and older;
- diagnosis of HIV;
- self-reported smoking on a daily basis;
- provide informed written consent
Key exclusion criteria (4 listed)
- persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)
- unable to understand spoken English
- age less than 18 years.
- pregnant women
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 tartrateAlso: Chantix1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12. | Drug | HIV Smoking Cessation Arm |
| Nicotine Replacement TherapyNicotine gum and nicotine patch | Drug | HIV Smoking Cessation Arm |
| Biological ControlNo treatment intervention only information and procedures. | Other | Healthy Control - Non-smoking, Healthy Control - Smoker |
| Motivational Interview60 minute one-on-one Interview | Behavioural | Motivational Intervention |
Primary outcome
To Determine the Safety of Varenicline in PLWH Who Smoke
Time frame: 3 months
To determine the safety and tolerability of varenicline compared to nicotine replacement
1 secondary outcome
To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
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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.
Philip T. Diaz, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varenicline tartrate, Nicotine Replacement Therapy and Motivational Interview in people with Smoking and HIV Infections, run by Philip Diaz 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 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 15 Jan 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 15 Jan 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?
To Determine the Safety of Varenicline in PLWH Who Smoke (time frame: 3 months). 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 NCT00701896, 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 15 Jan 2021.