Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts

Completed · Phase 2/Phase 3

Conditions studied: Tobacco Use Cessation

In brief

The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 16-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge (or gum, based on preference) on quit date (week 4), consistent with recommended guidelines based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge (or gum, based on preference), initiated on quit date. The investigators will examine dependence, urge to smoke and self-efficacy for quitting prior to and following quit date. The investigators will also examine differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8, 12, and 16.

Key facts

Study ID

NCT04994444

Run by

Brown University

People needed

49

Starts

2021-09-01

Expected to finish

2024-04-30

Last updated by the study team

2025-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• diagnosed with HIV
• at least 18 years of age
• smoking at least 5 cigarettes/day
• exhaled Carbon Monoxide level greater than 5 at baseline
• willing to use transdermal nicotine patch
• ready to quit in the next 30 days.

You may not qualify if…

• currently using pharmacotherapy for smoking cessation
• medically or psychiatrically unstable (defined as: uncontrolled hypertension, unstable angina, or a medical or psychiatric hospitalization in the 30 days prior to enrollment) *experiencing psychotic symptoms
• endorsing suicidal ideation upon screening or past-year suicide attempt
• pregnant or nursing.

Where it is running

• Brown University School of Public Health — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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