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Effects of Chantix on Relapse Prevention for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948649
First received: July 28, 2009
Last updated: August 16, 2010
Last verified: July 2009

July 28, 2009
August 16, 2010
September 2006
August 2007   (final data collection date for primary outcome measure)
Days of abstinence following the programmed lapse [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00948649 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Chantix on Relapse Prevention for Smoking Cessation
Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence

The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.

The proposed human experiment will test the validity of a novel paradigm that may provide a method for distinguishing compounds that are likely to have efficacy from those that are not, before they are tested in more costly large-scale clinical trials. Specifically, in a within-subject (cross-over) behavioral pharmacology investigation of 60 smokers, we will test the effects of varenicline versus placebo on smoking behavior in the natural environment following a 3-day period of monitored abstinence and a programmed cigarette lapse. A positive signal for varenicline effects in this study would provide support for the sensitivity of the paradigm. In addition, following completion of all assessments, participants will be followed in a 13-week open-label varenicline smoking cessation trial to determine whether response to varenicline in the laboratory study predicts clinical response in the open-label trial.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Screening
Nicotine Dependence
  • Drug: Placebo
    Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.
  • Drug: Varenicline
    Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - End of Treatment 1.0mg twice daily
    Other Name: Chantix
  • Active Comparator: Varenicline
    Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21).
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21).
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
September 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months.

Exclusion Criteria:

  • Smoking Behavior

    1. Use of chewing tobacco or snuff
    2. Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
    3. Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
    4. Provide a baseline CO reading < 10 ppm

Alcohol/Drug Exclusion Criteria

  1. History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
  2. Current alcohol consumption that exceeds >25 standard drinks/week

Medication Exclusion Criteria

1. Current use or recent discontinuation (within last 14-days) of the following medications:

  1. Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT)
  2. Any form of anti-psychotic medications that includes:

    • antipsychotics,
    • atypical antipsychotics,
    • mood-stabilizers,
    • anti-depressants (tricyclics, SSRI's, MAOI's),
    • anti-panic agents,
    • anti-obsessive agents,
    • anti-anxiety agents, and
    • stimulants (e.g., Provigil, Ritalin).
  3. Medication for chronic pain
  4. Anti-coagulants
  5. Any heart medications
  6. Daily medication for asthma

Medical Exclusion Criteria

  1. Women who are pregnant, planning a pregnancy, or lactating.
  2. History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder as identified by the SCID.
  3. Serious or unstable disease within the past 6 months (e.g., cancer [except melanoma], heart disease, HIV).
  4. History of epilepsy or a seizure disorder.
  5. History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP>150 or DBP>90)
  6. History of Kidney and/or liver failure (including transplant).
  7. Wears a device to aid in hearing (hearing aid, cochlear implant, etc.).
  8. Hearing threshold < 40 dB SPL at 1000 Hz.
  9. Color blindness.

General Exclusion

  1. Any medical condition or concomitant medication that could compromise participant 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.
  3. Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00948649
805394
No
Caryn Lerman, Ph.D., University of Pennsylvania
University of Pennsylvania
AstraZeneca
Principal Investigator: Caryn Lerman, Ph.D. University of Pennsylvania
University of Pennsylvania
July 2009

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