Status:

COMPLETED

E-cigarettes for Harm Reduction in Adults With Asthma

Lead Sponsor:

Brown University

Collaborating Sponsors:

National Institute of General Medical Sciences (NIGMS)

Conditions:

Smoking

Asthma

Eligibility:

All Genders

21-65 years

Phase:

NA

Brief Summary

Smoking is the main cause of preventable disease and death in the US and impacts respiratory illnesses including COPD and asthma. However, little is known about the effects on smoking and lung health ...

Detailed Description

This study will use an unequally allocated between-subjects (N=30) randomized, controlled design to investigate the influence of complimentary electronic nicotine delivery system (ENDS) provision on c...

Eligibility Criteria

Inclusion

  • Male or female (50%), 21 to 65 (inclusive) years of age;
  • Persistent asthma symptoms (i.e., episodic symptoms of airflow obstruction / airway hyperresponsiveness (AHR) as documented in review of medical history);
  • Currently prescribed SABA medication;
  • Past-year smoking of ≥5 cigarettes/day;
  • Exhaled CO ≥ 6 ppm at baseline;
  • Zero breath alcohol during informed consent for participation;
  • English-speaking at an 8th grade level.

Exclusion

  • Intention to quit smoking during the next 30 days;
  • Current engagement in any smoking cessation treatment;
  • Current self-identification as regular ENDS user or using ENDS \> 2 days / week;
  • Medical contraindication to nicotine;
  • Pregnancy (due to toxicity of nicotine and tobacco products);
  • Current alcohol dependence (AUDIT \> 15)
  • Urine-screened or past-month self-reported use of illicit substances (amphetamine, cocaine, methamphetamine, opioids, benzodiazepines);
  • Current psychosis, mania, or suicidal ideation;

Key Trial Info

Start Date :

May 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 12 2024

Estimated Enrollment :

17 Patients enrolled

Trial Details

Trial ID

NCT05278065

Start Date

May 1 2022

End Date

September 12 2024

Last Update

November 18 2025

Active Locations (1)

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1

Center for Alcohol and Addiction Studies

Providence, Rhode Island, United States, 02903