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NCT04994444 · ClinicalTrials.gov registry record · Phase 2
Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts
A Phase 2 study of Tobacco Use Cessation, sponsored by Brown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT04994444: Completed Phase 2 study of Tobacco Use Cessation, sponsored by Brown University.
NCT04994444 is a Phase 2 study of Tobacco Use Cessation that has completed, run by Brown University. The registered enrollment target is 49 participants, below the 883-participant average among 36 other Tobacco Use Cessation trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04994444, a Phase 2 study of Tobacco Use Cessation, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Number of days of nicotine patch use during the 8 weeks of provision
Conditions Studied
Interventions
- DRUG Nicoderm CQ 21Mg/24Hr Transdermal System
Study Locations (1)
Rhode Island
- Brown University School of Public Health - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 2 |
What the finished NCT04994444 record still lists
NCT04994444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 883-participant average among 36 other Tobacco Use Cessation trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Tobacco Use Cessation appearing as the primary indexed condition, and to 1 intervention - of which Nicoderm CQ 21Mg/24Hr Transdermal System is the first listed.
NCT04994444 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT04994444 about?
NCT04994444 is a clinical study titled "Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts". 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 succ...
What is the current status of trial NCT04994444?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2021-09-01. Estimated completion is 2024-04-30.
What conditions does trial NCT04994444 study?
This clinical trial studies the following conditions: Tobacco Use Cessation.
What interventions are being tested in trial NCT04994444?
The interventions under investigation include: Nicoderm CQ 21Mg/24Hr Transdermal System (DRUG).
Who is sponsoring clinical trial NCT04994444?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04994444 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tobacco Use Cessation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04994444's enrollment target sits among peer trials
49 33rd of 36 higher than 4 of 36 other Tobacco Use Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Use Cessation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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