Research & Collaboration

Built on evidence.
Designed to generate it.

Respiro is a direct-to-consumer telehealth platform studying whether asynchronous clinical care can substantially expand access to FDA-approved nicotine cessation medication. We welcome research collaboration, clinical partnership, and STTR co-investigator inquiries.

Get in Touch → Our Research Question

The Core Question

What we are trying to prove.

Varenicline is the most effective FDA-approved pharmacotherapy for nicotine cessation, with 12-week abstinence rates around 44% in cigarette-smoker trials — more than triple unassisted quit attempts.¹ Yet fewer than 35% of nicotine users who could benefit from pharmacotherapy ever receive it. The barriers are not clinical — they are access barriers. Scheduling delays, geographic limitations, insurance friction, and the discomfort of discussing nicotine use in a primary care setting.

Respiro was built to test a single hypothesis: that asynchronous telehealth delivery can close the access gap for evidence-based nicotine cessation pharmacotherapy at scale.

Primary Research Question

Does an asynchronous telehealth platform increase access to, initiation of, and completion of varenicline-based nicotine cessation treatment among people who would otherwise never receive pharmacotherapy?

This question has not been answered at scale in a DTC telehealth context. The 2025 JAMA trial from Harvard-affiliated Mass General Brigham demonstrated varenicline's efficacy in young adult vapers.³ What remains unstudied is whether a low-friction telehealth delivery model can reach the broader population of nicotine users — across cigarettes, vaping, pouches, and dip — who currently fall outside the traditional healthcare system.

Proposed Specific Aims

What a Phase I study would measure.

A Phase I feasibility study would evaluate Respiro's platform across 50-100 participants in a multi-state pilot, with the following primary aims:

Feasibility and Patient Acceptance

Evaluate whether patients complete intake, engage with the asynchronous review process, and initiate treatment at clinically meaningful rates. Measure intake-to-prescription time against traditional care benchmarks of 3–6 weeks.

Primary metric: Intake-to-prescription time

Treatment Completion and Abstinence

Measure 12-week continuous abstinence rates and protocol completion rates against published benchmarks for traditional care pathways. Verify abstinence via self-report with cotinine confirmation in a subset of participants.

Primary metric: 12-week abstinence rate

Access and Equity Metrics

Assess the proportion of enrolled participants who report no prior access to cessation pharmacotherapy, geographic distribution across rural and underserved areas, and differential outcomes by nicotine product type.

Primary metric: % previously unserved patients

Evidence Base

The clinical foundation we build on.

Respiro's protocol is grounded in the established clinical evidence for varenicline and emerging evidence for telehealth delivery of cessation care.

Finding	Evidence	Citation
44% 12-week abstinence (cigarette smokers)	Phase III RCT, varenicline vs placebo	Gonzales et al. JAMA 2006¹
3× more effective than unassisted quitting	Cochrane systematic review, NRT comparisons	Hartmann-Boyce et al. Cochrane 2022²
51% abstinence in young adult vapers at 12 weeks	First RCT of varenicline for vaping cessation, ages 16–25	Evins et al. JAMA 2025³
No increased neuropsychiatric risk	EAGLES trial: largest cessation safety RCT (n=8,144)	Anthenelli et al. Lancet 2016⁶
Telehealth increases cessation program reach	Systematic review of telehealth tobacco treatment	American Lung Association, 2022
<35% of eligible patients receive pharmacotherapy	National survey data on cessation treatment access	CDC / BRFSS 2024⁵

¹ Gonzales D, et al. JAMA. 2006;296(1):47-55. ² Hartmann-Boyce J, et al. Cochrane. 2022. ³ Evins AE, et al. JAMA. 2025;333(21):1876-1886. ⁴ U.S. FDA. Varenicline prescribing information. Current label. ⁵ CDC BRFSS 2024. ⁶ Anthenelli RM, et al. Lancet. 2016;387(10037):2507-2520.

The Access Gap

Why the problem is not clinical.

Varenicline works. The barrier to population-level impact is not efficacy — it is delivery. The traditional care pathway creates friction at every step that Respiro's model is designed to eliminate.

Traditional Care Pathway

×3–6 week wait for primary care appointment

×Geographic barriers — rural patients travel 30–60 min to PCP

×Nicotine use often deprioritized in 15-minute appointments

×Insurance prior authorization delays prescription access

×Social stigma reduces self-disclosure in clinical settings

×Result: <35% of eligible patients ever receive pharmacotherapy

Respiro Model

✓Online intake completed in under 5 minutes

✓Independent physician review within 24 hours — no travel required

✓Cessation-specific intake — every question is relevant

✓Cash-pay model — no insurance, no prior authorization

✓Private, async format reduces disclosure barrier

✓Research question: does this reach the 65% who currently don't?

Collaboration Opportunities

Who we are looking for.

Respiro is actively seeking research and clinical partnerships to strengthen the evidence base for our platform and support STTR Phase I application development.

STTR Co-Investigator

We are preparing a NIDA STTR Phase I application and seeking a scientific co-investigator with expertise in tobacco/nicotine cessation research, digital health interventions, or substance use disorders. The co-investigator would advise on study design, review the application, and be listed as a named investigator. If funded, participate in Phase I implementation. Consulting fee and publication authorship included.

Clinical Research Partner

University-affiliated tobacco treatment programs, cancer centers, or pulmonology practices interested in extending their reach through a validated telehealth delivery platform. Research data sharing, co-authorship on outcomes publications, and access to a national patient cohort.

Outcomes Research

Health outcomes researchers interested in studying DTC telehealth delivery models for cessation pharmacotherapy. Real-world data on treatment access, completion rates, and abstinence outcomes across diverse geographic and demographic groups.

Clinical Advisory

Board-certified physicians or Certified Tobacco Treatment Specialists (CTTS) interested in advising on clinical protocol development, contraindication screening design, and patient safety workflows. Paid advisory role.

Get In Touch

Let's talk research.

Whether you're a researcher, clinician, or potential collaborator — we'd love to hear from you. Responses within 48 hours.

✓

Message received.

We'll be in touch within 48 hours. Thank you for your interest in collaborating with Respiro.

Built on evidence.Designed to generate it.