Effects of Chantix on Relapse Prevention for Smoking Cessation

Nicotine Dependence Clinical Trial

Official title:

Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948649
• Other study ID #: 805394
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2009
• Last updated: August 16, 2010
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: July 2009
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Placebo
Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.
• 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

Locations

Country	Name	City	State
United States	Tobacco Use Research Center, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	AstraZeneca

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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 Oc — View 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/nt — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of abstinence following the programmed lapse		7 days	No