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Purpose

This project aims to investigate the impact of e-cigarette flavors and usage patterns on achieving harm-reduction milestones in a sample of cigarette smokers with opioid use disorder who are taking buprenorphine

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥21 years - Smoke ≥5 CPD for ≥1 year - Daily CC smoker - Willing to switch to EC - Exhaled CO ≥6 ppm - Diagnosed with OUD - Stable on bupropion treatment - In good physical and mental health - Able to use a smartphone - Willing to participate in all study components - Able to provide informed consent

Exclusion Criteria

  • Interested in quitting CC (contemplation stage of change) - Use of EC on ≥4 of the past 30 days - Use of other tobacco products (e.g., cigars, smokeless tobacco) on ≥9 days of the past 30 days - Use of nicotine replacement therapy, smoking cessation medication, or a cessation attempt in the past 30 days - Hypertension - Medical condition that would contraindicate participation - Meet DSM-V criteria for major depressive episode, psychotic episode, or manic episode - Current suicidal ideation or suicide attempt in the past year - Psychiatric hospitalization in the past year - Contemplating pregnancy, currently pregnant, or breastfeeding - Unable to speak and/or read English

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sweet-Cooling EC + Counseling 		Those randomized to the intervention group will be provided a free 12-week supply of sweet-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.
  • Behavioral: Brief individual counseling sessions
    Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC
Experimental
Sweet non-cooling EC + Counseling 		Those randomized to the intervention group will be provided a free 12-week supply of sweet non-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.
  • Behavioral: Brief individual counseling sessions
    Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC
Active Comparator
Tobacco-flavored EC + Counseling 		Those randomized to the intervention group will be provided a free 12-week supply of tobacco-flavored electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.
  • Behavioral: Brief individual counseling sessions
    Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC

Recruiting Locations

Addiction Medicine Center
Greenville, South Carolina 29605
Contact:
Alain Litwin, MD
864-455-5648
alain.litwin@prismahealth.org

More Details

Status
Recruiting
Sponsor
Prisma Health-Upstate

Study Contact

Irene Pericot-Valverde, PhD
(864)656-4467
iperico@clemson.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.