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Effects of Chantix on Relapse Prevention for Smoking Cessation

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Varenicline
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Nicotine Dependence focused on measuring Varenicline, Working memory

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tobacco Use Research Center, University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Varenicline

Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Days of abstinence following the programmed lapse

Secondary Outcome Measures

Full Information

First Posted
July 28, 2009
Last Updated
August 16, 2010
Sponsor
University of Pennsylvania
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00948649
Brief Title
Effects of Chantix on Relapse Prevention for Smoking Cessation
Official Title
Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pennsylvania
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Varenicline, Working memory

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varenicline
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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
Primary Outcome Measure Information:
Title
Days of abstinence following the programmed lapse
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Use of chewing tobacco or snuff Current enrollment or plans to enroll in another smoking cessation program in the next 5 months Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months Provide a baseline CO reading < 10 ppm Alcohol/Drug Exclusion Criteria History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants) 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: Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT) 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). Medication for chronic pain Anti-coagulants Any heart medications Daily medication for asthma Medical Exclusion Criteria Women who are pregnant, planning a pregnancy, or lactating. History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder as identified by the SCID. Serious or unstable disease within the past 6 months (e.g., cancer [except melanoma], heart disease, HIV). History of epilepsy or a seizure disorder. 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) History of Kidney and/or liver failure (including transplant). Wears a device to aid in hearing (hearing aid, cochlear implant, etc.). Hearing threshold < 40 dB SPL at 1000 Hz. Color blindness. General Exclusion Any medical condition or concomitant medication that could compromise participant 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. Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caryn Lerman, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tobacco Use Research Center, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18842256
Citation
Patterson F, Jepson C, Strasser AA, Loughead J, Perkins KA, Gur RC, Frey JM, Siegel S, Lerman C. Varenicline improves mood and cognition during smoking abstinence. Biol Psychiatry. 2009 Jan 15;65(2):144-9. doi: 10.1016/j.biopsych.2008.08.028. Epub 2008 Oct 8.
Results Reference
result
PubMed Identifier
20395358
Citation
Rudnick ND, Strasser AA, Phillips JM, Jepson C, Patterson F, Frey JM, Turetsky BI, Lerman C, Siegel SJ. Mouse model predicts effects of smoking and varenicline on event-related potentials in humans. Nicotine Tob Res. 2010 Jun;12(6):589-97. doi: 10.1093/ntr/ntq049. Epub 2010 Apr 15.
Results Reference
result
PubMed Identifier
19733449
Citation
Patterson F, Jepson C, Loughead J, Perkins K, Strasser AA, Siegel S, Frey J, Gur R, Lerman C. Working memory deficits predict short-term smoking resumption following brief abstinence. Drug Alcohol Depend. 2010 Jan 1;106(1):61-4. doi: 10.1016/j.drugalcdep.2009.07.020. Epub 2009 Sep 5.
Results Reference
result

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Effects of Chantix on Relapse Prevention for Smoking Cessation

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