| Eligibility |
Inclusion Criteria:
- Males and females 18 years of age or older who self-report smoking at least 5
cigarettes (menthol and non-menthol) per day, on average.
- HIV status
1. HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of
less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to
200 cells/mm3 within 12 months prior to enrollment.
2. HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid
HIV blood test.
- Able to use transdermal nicotine (TN) safely, based on a medical evaluation.
- Residing in the geographic area for at least 4 months.
- Women of childbearing potential (based on medical history) must consent to use a
medically accepted method of birth control (e.g., condoms and spermicide, oral
contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain
from sexual intercourse during the time they are in the study and using transdermal
nicotine.
- Able to communicate fluently in English.
- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the combined consent/HIPAA form.
Exclusion Criteria:
Smoking Behavior
1. Current enrollment or plans to enroll in another smoking cessation program in the next
4 months.
2. Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars,
cigarillos, or pipes.
3. Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or
smoking cessation treatments in the next 4 months.
Alcohol/Drug Exclusion Criteria
1. Current untreated and unstable diagnosis of substance dependence (eligible if past use
and if receiving treatment and stable for at least 30 days). Current untreated and
unstable diagnosis of substance abuse requires Study Physician approval.
2. A positive urine drug screen for cocaine, amphetamines, methamphetamines,
Phencyclidine (PCP), barbiturates, ecstasy (MDMA) at Intake (see Measures and Table 1
for details). At Lab 1 and Lab 2, positive urine drug screens will be reviewed on a
case-by-case basis. The PI will determine if the participant will be excluded or
allowed to reschedule the visit, at which time they must provide a negative drug
screen to continue with the study.
Medication Exclusion Criteria
Current use or recent discontinuation (within last 14 days) of the following medications:
1. Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin sustained
release (SR), Chantix)
a. Note: Once participants are found eligible for the study, they are instructed to
only use the NRT provided to them by the study staff. If a subject reports using a
non-study smoking cessation medication (including other forms of NRT), the study
physician and PI will evaluate the situation and determine if it is safe for the
subject to continue participation.
2. Anti-psychotic medications (if used to treat psychotic symptoms. Other uses may be
eligible pending physician approval).
3. Daily use of opiate-containing medications for chronic pain (Duragesic/fentanyl
patches, Percocet, Oxycontin). Smokers who report taking opiate-containing medications
on an "as-needed" basis will be instructed to refrain from use until their study
participation is over and that they will be tested to ensure they have complied with
this requirement.
4. Asthma medications/corticosteroids (requires physician approval)
5. Anti-depressants (require physician approval)
Medical Exclusion Criteria
1. Females who self-report current pregnancy, planning a pregnancy during the study, or
currently breastfeeding/lactating.
2. Current diagnosis of unstable and untreated major depression, as determined by
self-report & Mini International Neuropsychiatric Interview (MINI) (eligible if stable
for at least 30 days).
3. Current or past diagnosis of bipolar disorder or psychotic disorder, as determined by
self-report or MINI.
4. History of heart disease, stroke or MI, unstable angina, or tachycardia (if stable,
requires Study Physician approval).
5. Uncontrolled hypertension (systolic blood pressure (SBP) greater than 160 or diastolic
blood pressure (DBP) greater than 100) present at Intake.
a. Note: If a participant presents with blood pressure greater than 160/100 at
sessions occurring on Week 3 (Pre-Quit) or at any other point during the treatment
period, they will not be provided with/able to continue on TN unless the study
physician grants approval.
6. Previous allergic reaction to TN.
7. History of diabetes (requires Study Physician approval)
8. History of seizures (requires Study Physician approval)
9. History of stomach ulcers (requires Study Physician approval)
Suicide History Exclusion Criteria
1. Suicide risk as indicated by at least one of the following on the Columbia Suicide
Severity Rating Scale (the PI &/or study psychologist will be consulted to assess safety
and determine eligibility in cases close to the eligibility cutoffs):
1. Current suicidal ideation (within 30 days of enrollment)
2. Two or more lifetime suicide attempts
3. Any suicide attempt within 2 years of enrollment
General Exclusion Criteria
1. Any medical condition or concomitant medication that could compromise subject safety
or treatment, as determined by the Principal Investigator and/or Study Physician.
2. Color blindness.
3. Any impairment (physical and/or neurological) including visual or other impairment
preventing cognitive task performance.
4. Inability to provide informed consent or complete any of the study tasks as determined
by the Principal Investigator and/or Study Physician.
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