Nicotine DependencePhase 3NCT01710137
Varenicline for Nicotine Dependence Among Those With HIV/AIDS
A Phase 3 study testing Varenicline and Smoking Cessation Counseling in people with Nicotine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases to cardiovascular disease and lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Varenicline and Smoking Cessation Counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average.
- Diagnosed with HIV infection and exhibiting viral load of < 1000 copies/mL and CD4+ counts of > 200 cells/mm3 within 6 months prior to enrollment.
- Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
- Residing in the geographic area for at least 7 months.
- Women of childbearing potential (based on medical history and physical exam) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are taking study medication and for at least one month after the medication period ends.
- If current or past diagnosis of bipolar disorder (I, II, or NOS), eligible if:
Show all 13Show fewer
- No psychotic features
- MADRS: total score < 8 (past 4 weeks), suicidal item score < 1 (past 4 weeks)
- Y-MRS: total score < 8 (past 4 weeks), irritability, speech content, disruptive, or aggressive behavior items score < 3 (past 4 weeks)
- No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months
- No aggressive or violent acts or behavior in the past 6 months
- Able to communicate fluently in English.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.
Who cannot join
- Smoking Behavior
- Current enrollment or plans to enroll in another smoking cessation program in the next 7 months.
- Regular (daily) use of chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
- Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 7 months.
- Note: Once participants are found eligible for the study, they are told they should refrain from using any nicotine replacement therapy (NRT) for the duration of the study. If a subject reports an isolated (non-daily) instance of NRT use during the study, they may be permitted to continue.
- Alcohol/Drug Exclusion Criteria
Show all 31Show fewer
- Current untreated and unstable diagnosis of substance abuse or dependence (eligible if past use and if receiving treatment and stable for >30 days).
- Positive urine drug screen (for cocaine and/or methamphetamines) at the Intake Session.
- Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at the Intake Session.
- Medication Exclusion Criteria
- Current use or recent discontinuation (within last 14 days) of the following medications:
- Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix)
- Note: Once participants are found eligible for the study, they are instructed to only use the smoking cessation medication provided to them by the study staff. If a subject reports an isolated (non-daily) instance of using a non-study smoking cessation medication, the study physician and PI will evaluate the situation and determine if it is safe for the subject to continue participation.
- Anti-psychotic medications.
- Medical Exclusion Criteria
- Women who are pregnant, planning a pregnancy within the next 7 months, or lactating.
- Current diagnosis of unstable and untreated major depression, as determined by self-report \& MINI (eligible if stable for >30 days).
- Current or past diagnosis of psychotic disorder, as determined by self-report or MINI.
- Any suicide risk score on MINI, current suicidal ideation on Columbia scale, or self-reported lifetime suicide attempt.
- History of heart disease, stroke or MI, unstable angina, or tachycardia (if stable, requires Study Physician approval).
- Uncontrolled hypertension (SBP >160 or DBP >100).
- Note: If a participant presents with blood pressure greater than 160/100 at sessions occurring on Week 0 (Pre-Quit) or at any other point during the treatment period, they will not be provided with/able to continue on medication unless the study physician grants approval.
- History of kidney or liver failure.
- Abnormal ECG (unless approved by study physician).
- Estimated creatinine clearance <50 mL/min, within 6 months prior to enrollment.
- AST and/or ALT results greater than 2 times the upper limit of normal, within 6 months prior to enrollment.
- Any impairment (physical, neurological, visual) preventing cognitive task performance.
- Previous allergic reaction to varenicline.
- General Exclusion Criteria
- Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2) quality of life will be rated higher in the varenicline and counseling group versus the placebo and counseling group, and there will be no significant differences between treatment arms in terms of the frequency of severe varenicline-related side effects; and 3) improved affect and reduced cognitive impairment will mediate the effect of varenicline therapy on quit rates.
Read the detailed description
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases (e.g., non-Hodgkin's lymphoma, Kaposi sarcoma), to cardiovascular disease and lung cancer. As such, addressing modifiable risk factors for disease mortality among those with HIV/AIDS, including tobacco use, has become a critical priority. To date, only three smoking cessation clinical trials have been conducted with those with HIV/AIDS none of which investigated the efficacy of FDA-approved medications for nicotine dependence. Varenicline is an α4β2 nicotinic acetylcholine receptor partial agonist with greater efficacy for treating nicotine dependence than bupropion or nicotine patch. Varenicline may be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS given that depression symptoms and cognitive impairment are common in this population, increase during smoking abstinence and predict smoking relapse, and are significantly reduced by varenicline. Therefore, the investigators will conduct a randomized, double-blind, placebo-controlled trial of varenicline with smokers with HIV/AIDS. Specifically, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The primary outcome variable for this study will be 7-day biochemically confirmed tobacco abstinence at weeks 12 and 24. Secondary outcomes include: prolonged abstinence to week 12, 18, and 24 (relapse defined as 7 consecutive days of self-reported smoking, after a 2-week grace period), continuous abstinence at weeks 12 and 24 (e.g., no smoking between quit day and follow-up), time to 7-day relapse (no grace period), and lapse and recovery events. The trial results may support the use of varenicline for the treatment of nicotine dependence among those with HIV/AIDS, thereby reducing tobacco-related morbidity and mortality in this population.
- Conditions
- Nicotine Dependence
- Being tested
- Varenicline, Placebo, Smoking Cessation Counseling
- Keywords
- Smoking cessation, Nicotine dependence, Varenicline, Chantix, HIV, AIDS
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
PlaceboDrug
Smoking Cessation CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Active comparator | 12 weeks of active varenicline + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Receives: Drug: Varenicline; Behavioral: Smoking Cessation Counseling |
| Placebo | Placebo comparator | 12 weeks of placebo + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Receives: Drug: Placebo; Behavioral: Smoking Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point Prevalence Tobacco Abstinence
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
Measured: Week 12
Point Prevalence Tobacco Abstinence
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
Measured: Week 24
Secondary outcomes (5)
Quality of Life at Week 12
The HIV/AIDS-Targeted Quality of Life scale measures overall functioning. Scale range from 7 - 35. Higher score indicates worse quality of life.
Measured: Week 12
Continuous Abstinence to Week 12
No smoking between the quit day and the follow-up (week 12).
Measured: Weeks 12
Continuous Abstinence to Week 24
No smoking between the quit day and the follow-up (Week 24).
Measured: Weeks 24
Time to 7-day Relapse
days to smoking regularly for 7 days
Measured: Week 24
Point Prevalence Tobacco Abstinence
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
Measured: Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2018
- Study completionSep 2018
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 Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Robert A Schnoll, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710137
- Sponsor's protocol ID
- R01DA033681-01
- Other IDs
- 815435, R01DA033681
- Status last verified
- Sep 2019
- First submitted
- 8 Oct 2012
- Last updated
- 18 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ashare RL, Thompson M, Leone F, Metzger D, Gross R, Mounzer K, Tyndale RF, Lerman C, Mahoney MC, Cinciripini P, George TP, Collman RG, Schnoll R. Differences in the rate of nicotine metabolism among smokers with and without HIV. AIDS. 2019 May 1;33(6):1083-1088. doi: 10.1097/QAD.0000000000002127.
PubMed 30946162
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS
- ClinicalTrials.gov ID
- NCT01710137
- Acronym / sponsor ID
- R01DA033681-01
- Conditions
- Nicotine Dependence
- Keywords
- Smoking cessation, Nicotine dependence, Varenicline, Chantix, HIV, AIDS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2012
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2) quality of life will be rated higher in the varenicline and counseling group versus the placebo and counseling group, and there will be no significant differences between treatment arms in terms of the frequency of severe varenicline-related side effects; and 3) improved affect and reduced cognitive impairment will mediate the effect of varenicline therapy on quit rates.
Detailed description
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases (e.g., non-Hodgkin's lymphoma, Kaposi sarcoma), to cardiovascular disease and lung cancer. As such, addressing modifiable risk factors for disease mortality among those with HIV/AIDS, including tobacco use, has become a critical priority. To date, only three smoking cessation clinical trials have been conducted with those with HIV/AIDS none of which investigated the efficacy of FDA-approved medications for nicotine dependence. Varenicline is an α4β2 nicotinic acetylcholine receptor partial agonist with greater efficacy for treating nicotine dependence than bupropion or nicotine patch. Varenicline may be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS given that depression symptoms and cognitive impairment are common in this population, increase during smoking abstinence and predict smoking relapse, and are significantly reduced by varenicline. Therefore, the investigators will conduct a randomized, double-blind, placebo-controlled trial of varenicline with smokers with HIV/AIDS. Specifically, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The primary outcome variable for this study will be 7-day biochemically confirmed tobacco abstinence at weeks 12 and 24. Secondary outcomes include: prolonged abstinence to week 12, 18, and 24 (relapse defined as 7 consecutive days of self-reported smoking, after a 2-week grace period), continuous abstinence at weeks 12 and 24 (e.g., no smoking between quit day and follow-up), time to 7-day relapse (no grace period), and lapse and recovery events. The trial results may support the use of varenicline for the treatment of nicotine dependence among those with HIV/AIDS, thereby reducing tobacco-related morbidity and mortality in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Active comparator | Drug: Varenicline, Behavioral: Smoking Cessation Counseling12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Smoking Cessation Counseling12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average.
- Diagnosed with HIV infection and exhibiting viral load of < 1000 copies/mL and CD4+ counts of > 200 cells/mm3 within 6 months prior to enrollment.
- Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
- Residing in the geographic area for at least 7 months.
- Women of childbearing potential (based on medical history and physical exam) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are taking study medication and for at least one month after the medication period ends.
Key exclusion criteria (31 listed)
- Smoking Behavior
- Current enrollment or plans to enroll in another smoking cessation program in the next 7 months.
- Regular (daily) use of chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
- Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 7 months.
- Alcohol/Drug Exclusion Criteria
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 |
|---|---|---|
| VareniclineAlso: Chantix | Drug | Varenicline |
| Placebo | Drug | Placebo |
| Smoking Cessation Counseling | Behavioural | Placebo, Varenicline |
Primary outcome
Point Prevalence Tobacco Abstinence
Time frame: Week 12
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
Point Prevalence Tobacco Abstinence
Time frame: Week 24
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
5 secondary outcomes
Quality of Life at Week 12
Time frame: Week 12
Continuous Abstinence to Week 12
Time frame: Weeks 12
Continuous Abstinence to Week 24
Time frame: Weeks 24
Time to 7-day Relapse
Time frame: Week 24
Point Prevalence Tobacco Abstinence
Time frame: Week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30946162Ashare RL, Thompson M, Leone F, Metzger D, Gross R, Mounzer K, Tyndale RF, Lerman C, Mahoney MC, Cinciripini P, George TP, Collman RG, Schnoll R. Differences in the rate of nicotine metabolism among smokers with and without HIV. AIDS. 2019 May 1;33(6):1083-1088. doi: 10.1097/QAD.0000000000002127.
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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.
Robert A Schnoll, PhD principal investigator
University of Pennsylvania
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 Smoking Cessation Counseling in people with Nicotine Dependence, run by University of Pennsylvania 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 13 inclusion and 31 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 18 Sep 2019. 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 6 Sep 2019). 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?
Point Prevalence Tobacco Abstinence (time frame: Week 12). The study lists 2 primary outcomes in all. 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 NCT01710137, 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 18 Sep 2019.