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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
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Drug: Placebo
Drug: Varenicline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Screening
Official Title: Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Days of abstinence following the programmed lapse [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
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).
Drug: Placebo
Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948649

Locations
United States, Pennsylvania
Tobacco Use Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
AstraZeneca
Investigators
Principal Investigator: Caryn Lerman, Ph.D. University of Pennsylvania
  More Information

Publications:
Responsible Party: Caryn Lerman, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948649     History of Changes
Other Study ID Numbers: 805394
Study First Received: July 28, 2009
Last Updated: August 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Varenicline, Working memory

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014