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Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in SUD Treatment

Primary Purpose

Tobacco Dependence Caused by Cigarettes

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIDA Standardized Research Electronic Cigarette
Sponsored by
University of Nevada, Reno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence Caused by Cigarettes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: currently engaged in outpatient treatment the Mathewson Institute (medication, behavioral, or combination treatment) aged 21+ interested in switching from cigarettes to e-cigarettes, assessed by the item "Are you interested in replacing some or all of your cigarettes with e-cigarettes?" has a cellphone with an unlimited text message plan has had the same phone number for at least 1 month uses text messages at least once a week self-reports daily smoking records an exhaled air carbon monoxide (CO) level >6ppm at baseline study visit has the capacity to understand the participant materials and follow the study procedures (e.g. sufficient English language ability). Exclusion Criteria: Individuals who meet any the following criteria will not be enrolled in this study: have used an e-cigarette to quit smoking in the past month are currently pregnant or breast-feeding.

Sites / Locations

  • University of Nevada, Reno

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E-cigarette arm

Arm Description

Participants will receive the NIDA Standardize Research E-Cigarette (SREC), nicotine pods (1 of each available flavor, for a total of 4 pods), and tailored instructions to switch. Participants will use the SREC ad libitum for 14 days, reporting their cigarette use, e-cigarette use, mood, and nicotine crazing every day via text message surveys.

Outcomes

Primary Outcome Measures

Change in average number of cigarettes consumed - Week 2 vs. Week 1
Change in average cigarette consumption per day as a function of daily e-cigarette use
Change in average number of cigarettes consumed - Week 3 vs. Week 1
Change in average cigarette consumption per day as a function of daily e-cigarette use

Secondary Outcome Measures

Full Information

First Posted
June 15, 2023
Last Updated
September 25, 2023
Sponsor
University of Nevada, Reno
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1. Study Identification

Unique Protocol Identification Number
NCT05918887
Brief Title
Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in SUD Treatment
Official Title
Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in Substance Use Disorder Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Reno

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the proposed study is to examine the feasibility of integrating a smoking harm reduction program featuring provision of e-cigarettes and tailored instructions to switch into an existing substance use disorder treatment program. This longitudinal study includes three weeks of micro-surveys delivered via text messages to evaluate the intervention's feasibility and acceptability, gather initial effectiveness data, and understand participants' lived experience of smoking and vaping while engaged in substance use disorder treatment.
Detailed Description
Up to 30 daily cigarette smokers who are engaged in a substance use disorder treatment program and are not interested in quitting nicotine use but are interested in reducing the harm from smoking will be enrolled in the study. As people gain access to substance use disorder treatment and the acute risk of death due to overdose diminishes, there is a significant need for data-driven, novel, and scalable smoking harm reduction approaches that meet people in recovery "where they are" and help them live longer, healthier lives by either significantly reducing their smoking frequency or switching completely to a much lower harm nicotine product. Our overall aims are to: Aim 1. Examine the feasibility (e.g., enrollment, attrition), acceptability (e.g., e-cigarette use rates, user experience), and effectiveness (e.g., % who reduced smoking by at least 50% in Week 3 vs. Week 1; % who switched completely at Week 3) of the intervention on cigarette smoking among people engaged in substance use disorder treatment. It is anticipated that of the 30 people enrolled, 20 will complete the protocol. In Week 1, participants will report their usual smoking to establish baseline behavior. In Week 2, participants will be provided with an e-cigarette, nicotine liquid, and instructions to switch developed in Aim 1. In Week 3, participants' nicotine liquid supply will be replenished and data collection will continue. Aim 2. Describe participants' understanding of the meaning and utility of cigarettes and e-cigarettes in their lives. Up to 20 participants will take part in a semi-structured interview at the end of Week 3. Interviews will focus on their experience trying to switch while engaged in substance use disorder treatment and how their cognitions, expectancies, social relationships, and norms evolved over the 2 weeks of e-cigarette use. Qualitative data will add context and explanation to quantitative data collected in Aim 1 and will identify opportunities to improve the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence Caused by Cigarettes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-cigarette arm
Arm Type
Experimental
Arm Description
Participants will receive the NIDA Standardize Research E-Cigarette (SREC), nicotine pods (1 of each available flavor, for a total of 4 pods), and tailored instructions to switch. Participants will use the SREC ad libitum for 14 days, reporting their cigarette use, e-cigarette use, mood, and nicotine crazing every day via text message surveys.
Intervention Type
Other
Intervention Name(s)
NIDA Standardized Research Electronic Cigarette
Intervention Description
The Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices. Nicotine pods: Sealed, pre-filled, non-refillable 1.9 mL e-liquid with 5% w/w nicotine (placebo also available) Approx 300 (280-330) puffs/pod Nicotine liquid characteristics: Volume of liquid per pod 1.9 mL Active (nicotine USP 5% wt/wt) and placebo (nicotine 0%) Propylene Glycol USP & Vegetable Glycerin USP - PG/VG Ratio 0.77 Lactic Acid USP Battery characteristics: USB Rechargeable Storage Capacity ~ 400 mAh Approx 200 (3s) puffs / charge 300 charge cycles to > 80% initial capacity Time to full charge 75 - 85 min Voltage / Temperature settings not user adjustable
Primary Outcome Measure Information:
Title
Change in average number of cigarettes consumed - Week 2 vs. Week 1
Description
Change in average cigarette consumption per day as a function of daily e-cigarette use
Time Frame
Week 2 vs. Week 1
Title
Change in average number of cigarettes consumed - Week 3 vs. Week 1
Description
Change in average cigarette consumption per day as a function of daily e-cigarette use
Time Frame
Week 3 vs. Week 1
Other Pre-specified Outcome Measures:
Title
Smoking reduction
Description
Percent of participants who reduced their smoking by at least 50%
Time Frame
Week 3 vs. Week 1
Title
Complete switching to e-cigarettes
Description
Percent of participants who completely switched to e-cigarettes by the end of Week 3
Time Frame
Week 3
Title
Attrition
Description
Percent of people who consent to participate in the study but do not complete the protocol
Time Frame
Week 3 vs. Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: currently engaged in outpatient treatment the Mathewson Institute (medication, behavioral, or combination treatment) aged 21+ interested in switching from cigarettes to e-cigarettes, assessed by the item "Are you interested in replacing some or all of your cigarettes with e-cigarettes?" has a cellphone with an unlimited text message plan has had the same phone number for at least 1 month uses text messages at least once a week self-reports daily smoking records an exhaled air carbon monoxide (CO) level >6ppm at baseline study visit has the capacity to understand the participant materials and follow the study procedures (e.g. sufficient English language ability). Exclusion Criteria: Individuals who meet any the following criteria will not be enrolled in this study: have used an e-cigarette to quit smoking in the past month are currently pregnant or breast-feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Pearson, PhD
Phone
7756825005
Email
jennipearson@unr.edu
Facility Information:
Facility Name
University of Nevada, Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in SUD Treatment

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