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Cognition and Smoking Relapse (HCS)

NCT03169101 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 274

Last updated 2024-05-10

Study results available
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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.

Conditions

  • Smoking Cessation

Interventions

DRUG

Nicotine patch

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

Behavioral counseling

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

Sponsors & Collaborators

Principal Investigators

  • Rebecca L Ashare, Ph.D. · University of Pennsylvania

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2022-04-21
Completion
2022-04-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03169101 on ClinicalTrials.gov