N/A
Completed N=488
Patch Study - Intervention for HIV Positive Smokers
Source: ClinicalTrials.gov NCT02982772 ↗Enrolled (actual)
488
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Rates of Smoking Cessation — 57; 46 Participants
Summary
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. To test researchers proposed model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines + nicotine replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Smoking Cessation |
32; 28 | — |
| SECONDARY Change in Clinical Outcomes |
0.85; 0.82 | — |
| SECONDARY Number of Participants With Verified Continuous Abstinence |
32; 28 | — |
| SECONDARY Prevalence of Side Effects-safety |
31; 33 | — |
Eligibility Criteria
Inclusion Criteria
- HIV infected smokers
- 18 years of age and older
- Fluent in English or Spanish
- Able to consent
- Ready to quit smoking
Exclusion Criteria
- Psychotic or disabling psychiatric disorders
- Six months post-myocardial infarction or stroke
- Diabetes requiring insulin
- Treatment for vascular problems
- Non-treated hypertension,
- Severe liver or kidney disease
- History of allergies to the nicotine patches
- Severe eczema or psoriasis
- Temporal-mandibular joint disease or dental appliances
- Pregnant women or women that are breastfeeding
- Subjects participating in other interventions/research
Data sourced from ClinicalTrials.gov (NCT02982772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.