Effects of Chantix on Relapse Prevention for Smoking Cessation

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: AstraZeneca
• Treatments: Varenicline

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.