NCT04994444CompletedPhase 2/3
Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts
Source: ClinicalTrials.gov · Last updated 6 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 29 Jul 2021
- Start date
- Sept 2021
- Primary completion date
- Apr 2024
- Lead sponsor
- Brown University
- NCT number
- NCT04994444
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 49
- From Sept 2021 to the primary completion date, Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- endorsing suicidal ideation upon screening or past-year suicide attempt
- pregnant or nursing.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brown University School of Public Health Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.