Cognition & Smoking Relapse (HCS)

Status Completed

Clinical Trial 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.

Clinical Trial Description

Medical advances in the treatment of HIV/AIDS have improved the life expectancy of HIV-infected individuals. Unfortunately, HIV-infected individuals are three times more likely to use tobacco than those in the general population, but little is known about the mechanisms that underlie these high smoking rates. This will be the first study to test whether the neurocognitive impairments associated with HIV-1 infection may be exacerbated during nicotine withdrawal and increase the probability of smoking relapse among HIV-infected smokers (HIV+), compared to HIV-uninfected smokers (HIV-). To this end, adult treatment-seeking smokers (N=300; 150 HIV+ and 150 HIV-) will complete this 12-week study, which is divided into two phases: a pre-quit laboratory phase (weeks 0-2) and a treatment phase (weeks 3-12). Subjects will complete two laboratory sessions during the pre-quit phase: once following 24 hours of mandatory smoking abstinence and once while smoking-as-usual (order counterbalanced). A comprehensive cognitive task battery assessing memory, attention, and executive function will be administered during each laboratory session. During the treatment phase, all subjects will receive standard smoking cessation treatment, including counseling (weeks 3-8) and open-label transdermal nicotine (TN) patches (weeks 4-12). The primary outcomes are: 1) cognitive performance following 24-hours smoking abstinence (vs. smoking-as-usual) during the pre-quit phase; and 2) 7-day point-prevalence, biochemically-confirmed abstinence rates at the end-of-treatment (EOT) for the treatment phase. ;

Study Design

Related Conditions & MeSH terms

Smoking Cessation

Clinical Trial Details

NCT number	NCT03169101
Study type	Observational
Source	University of Pennsylvania
Contact
Status	Completed
Phase
Start date	July 1, 2016
Completion date	April 25, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cognition and Smoking Relapse (HCS) — HCS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms