CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 274 enrolled
Drug / intervention
Nicotine patch +1 moredrug
Likely dose
Nicotine patch in tapering fashion as recommended by manufacturer; dose varies by baseline smoking (≥10 or <10 cigarettes/day)AI-extracted
Key inclusion· 6
  • ✓Age ≥18 years and smoking ≥5 cigarettes per day (menthol and non-menthol)
  • ✓HIV-infected participants: viral load ≤1000 copies/mL and CD4+ ≥200 cells/mm³ within 12 months prior to enrollment
  • ✓HIV-uninfected status confirmed by on-site rapid HIV blood test
  • ✓Able to use transdermal nicotine safely based on medical evaluation
Key exclusion· 12
  • ✕Current enrollment or plans to enroll in another smoking cessation program within 4 months
  • ✕Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes
  • ✕Current use or plans to use nicotine substitutes or smoking cessation treatments within 4 months
  • ✕Current untreated and unstable substance dependence or abuse (unless past use with ≥30 days stable treatment)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03169101
NCT03169101N/ACompleted
CompareCT.gov

Understanding the Role of Cognitive Dysfunction in the Treatment of Nicotine Dependence Among HIV-infected Smokers

University of Pennsylvania·observational·Posted May 30, 2017·Updated May 10, 2024

In Brief

An observational study evaluating Nicotine patch and Behavioral counseling for Smoking Cessation. Completed, enrolled 274 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartJul 1, 2016
Primary CompletionApr 21, 2022
Study CompletionApr 25, 2022
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 9.1 years ago

Interventions

Nicotine patchdrug

All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.

Behavioral counselingbehavioral

Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).