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N/A N=241

Cognition and Smoking Relapse (HCS)

Smoking Cessation

Enrolled (actual)
241
Serious AEs
1.0%
Results posted
May 2024
Primary outcome: Primary: Cognitive Function — 0.125; -.093; -.059; -.008 z-score

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Nicotine patch (Drug); Behavioral counseling (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pennsylvania
Primary completion
Apr 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Cognitive Function
0.125; -.093; -.059; -.008; .043; -.012
SECONDARY
7-day Point Prevalence Abstinence
22; 33

Summary

This study tests whether withdrawal-related cognitive deficits increase smoking relapse among HIV-infected (HIV+) vs. HIV-uninfected smokers (HIV-). Adult smokers (N=300; 150 HIV+, 150 HIV-) will complete 2 sessions to assess cognition (24h abstinence vs. smoking-as-usual; order counterbalanced; weeks 0-2). Subjects will then receive smoking cessation counseling and open label transdermal nicotine (weeks 3-12). Outcomes are: 1) cognition; and 2) abstinence rates at the end-of-treatment.

Eligibility Criteria

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
  • 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.
  • 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

  • Current enrollment or plans to enroll in another smoking cessation program in the next 4 months.
  • Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
  • 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

  • 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.
  • 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:

  • 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.

  • Anti-psychotic medications (if used to treat psychotic symptoms. Other uses may be eligible pending physician approval).
  • 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.
  • Asthma medications/corticosteroids (requires physician approval)
  • Anti-depressants (require physician approval)

Medical Exclusion Criteria

  • Females who self-report current pregnancy, planning a pregnancy during the study, or currently breastfeeding/lactating.
  • 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).
  • Current or past diagnosis of bipolar disorder or psychotic disorder, as determined by self-report or MINI.
  • History of heart disease, stroke or MI, unstable angina, or tachycardia
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03169101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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