Varenicline for Nicotine Dependence Among Those With HIV/AIDS

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01710137
First received: October 8, 2012
Last updated: August 12, 2014
Last verified: August 2014

October 8, 2012
August 12, 2014
October 2012
January 2017   (final data collection date for primary outcome measure)
  • Point prevalence tobacco abstinence [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
  • Point prevalence tobacco abstinence [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
Same as current
Complete list of historical versions of study NCT01710137 on ClinicalTrials.gov Archive Site
  • Quality of Life [ Time Frame: Weeks 12 & 24 ] [ Designated as safety issue: Yes ]
    The HIV/AIDS-Targeted Quality of Life scale measures overall functioning, which will be the primary measure of QOL for this study, but several subscales of QOL are also included such as life satisfaction, health worries, HIV mastery, financial worries, and disclosure worries. In addition, the investigators will compare treatment arms in terms of the frequency of severe side effects (individual and total).
  • Prolonged Abstinence [ Time Frame: Weeks 12 & 24 ] [ Designated as safety issue: No ]
    Relapse is 7 consecutive days of self-reported smoking, after a 2-week grace period.
  • Continuous Abstinence [ Time Frame: Weeks 12 & 24 ] [ Designated as safety issue: No ]
    No smoking between the quit day and the follow-up; no smoking during weeks 9-12 as measured in previous varenicline trials with the general population of smokers.
  • Time to 7-day relapse [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Smoking Rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Monitor changes in smoking rates (i.e., # cigarettes/day).
  • Lapse & Recovery Events [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Timing and rates of lapses (smoking episodes not lasting 7 days) and recovery events (return to 24-hour abstinence).
  • Point prevalence tobacco abstinence [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
    7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
Same as current
Not Provided
Not Provided
 
Varenicline for Nicotine Dependence Among Those With HIV/AIDS
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Nicotine Dependence
  • Drug: Varenicline
    Other Name: Chantix
  • Drug: Placebo
  • Behavioral: Smoking Cessation Counseling
  • Active Comparator: Varenicline

    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

    Interventions:
    • Drug: Varenicline
    • Behavioral: Smoking Cessation Counseling
  • Placebo Comparator: Placebo

    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

    Interventions:
    • Drug: Placebo
    • Behavioral: Smoking Cessation Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
June 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average.
  2. 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.
  3. Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
  4. Residing in the geographic area for at least 7 months.
  5. 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.
  6. If current or past diagnosis of bipolar disorder (I, II, or NOS), eligible if:

    1. No psychotic features
    2. MADRS: total score < 8 (past 4 weeks), suicidal item score < 1 (past 4 weeks)
    3. Y-MRS: total score < 8 (past 4 weeks), irritability, speech content, disruptive, or aggressive behavior items score < 3 (past 4 weeks)
    4. No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months
    5. No aggressive or violent acts or behavior in the past 6 months
  7. Able to communicate fluently in English.
  8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.

Exclusion Criteria:

Smoking Behavior

  1. Current enrollment or plans to enroll in another smoking cessation program in the next 7 months.
  2. Regular (daily) use of chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
  3. Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 7 months.

    1. 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

  1. Current untreated and unstable diagnosis of substance abuse or dependence (eligible if past use and if receiving treatment and stable for >30 days).
  2. Positive urine drug screen (for cocaine and/or methamphetamines) at the Intake Session.
  3. 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:

  1. Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix)

    a. 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.

  2. Anti-psychotic medications.

Medical Exclusion Criteria

  1. Women who are pregnant, planning a pregnancy within the next 7 months, or lactating.
  2. Current diagnosis of unstable and untreated major depression, as determined by self-report & MINI (eligible if stable for >30 days).
  3. Current or past diagnosis of psychotic disorder, as determined by self-report or MINI.
  4. Any suicide risk score on MINI, current suicidal ideation on Columbia scale, or self-reported lifetime suicide attempt.
  5. History of heart disease, stroke or MI, unstable angina, or tachycardia (if stable, requires Study Physician approval).
  6. Uncontrolled hypertension (SBP >160 or DBP >100).

    a. 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.

  7. History of kidney or liver failure.
  8. Abnormal ECG (unless approved by study physician).
  9. Estimated creatinine clearance <50 mL/min, within 6 months prior to enrollment.
  10. AST and/or ALT results greater than 2 times the upper limit of normal, within 6 months prior to enrollment.
  11. Any impairment (physical, neurological, visual) preventing cognitive task performance.
  12. Previous allergic reaction to varenicline.

General Exclusion Criteria

  1. Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigator and/or Study Physician.
  2. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
Both
18 Years and older
No
Contact: Amanda M Kaufmann 215-746-8434 akau@mail.med.upenn.edu
United States
 
NCT01710137
R01 DA033681-01, 815435, R01DA033681
Yes
Robert Schnoll, University of Pennsylvania
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Principal Investigator: Robert A Schnoll, PhD University of Pennsylvania
University of Pennsylvania
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP