Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine

N/ANot Yet RecruitingNCT07202039

Prisma Health-Upstate90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tobacco-flavored EC Sweet-Cooling EC Sweet Non-cooling EC

Interventions

Brief individual counseling sessionsBEHAVIORAL

Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Addiction Medicine Center

Greenville, South Carolina, United States

Outcomes

Primary Outcomes

Change in cigarettes smoked per day

The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to weeks 12

Time frame: Baseline to week 12

Secondary Outcomes

Change in cigarettes smoked per day

The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to week 24

Time frame: Baseline to week 24

Percentage of participants with a ≥50% reduction in CPD

The rate of participants achieving an average ≥50% reduction in CPD from baseline (week 0) to weeks 12 and 26, based on a 7-day TLFB

Time frame: Baseline to weeks 12 and 26

Switching

Proportion of participants reporting exclusive EC use and no CC use on a 7-day TLFB with CO \<6 ppm.

Time frame: Weeks 12 and 24

Partial Switching

Proportion of participants reporting both EC and CC use on a 7-day TLFB with a ≥50% reduction in CPD.

Time frame: Weeks 12 and 24

7-Day CC Abstinence

Percentage of participants with biochemically verified 7-day abstinence (1 = abstinent, 0 = non-abstinent). Defined as self-reported no CC use on a 7-day TLFB with CO \<6 ppm.

Time frame: Weeks 12 and 26

Change in carbon monoxide levels

Change in exhaled CO levels from baseline (week 0) to weeks 12 and 26 (continuous variable).

Time frame: Baselone to weeks 12 and 26

Central Contacts

Irene Pericot-Valverde, PhD

CONTACT

(864)656-4467 iperico@clemson.edu

Data from ClinicalTrials.gov

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