Varenicline for Nicotine Dependence Among Those With HIV/AIDS

ClinicalTrials.gov ID: NCT01710137

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Official title

A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2) quality of life will be rated higher in the varenicline and counseling group versus the placebo and counseling group, and there will be no significant differences between treatment arms in terms of the frequency of severe varenicline-related side effects; and 3) improved affect and reduced cognitive impairment will mediate the effect of varenicline therapy on quit rates.

Study identification

NCT ID: NCT01710137
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: University of Pennsylvania; Other
Enrollment: 179 participants

Conditions and interventions

Conditions

Nicotine Dependence

Interventions

Drug · Behavioral

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2012 (Type not available)
Primary completion: Sep 2018 (Actual)
Completion: Sep 2018 (Actual)
Last update posted: Sep 18, 2019

2012 – 2018

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
University of Pennsylvania	Philadelphia	Pennsylvania	19104	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01710137, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 18, 2019 · Synced Nov 13, 2026