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

NCT05918887 | Completed DMC FDA Device

• 1 other identifier: 2040809
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence Caused by Cigarettes

Outcome Measures

Primary Outcomes (2)

• 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

  Week 2 vs. Week 1

• 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

  Week 3 vs. Week 1

Secondary Outcomes (5)

• Recruitment feasibility

  Week 1

• Attrition feasibility

  Through study completion, up to Week 4

• Adherence fidelity

  Weeks 2 and 3

• EMA scheduled prompt feasibility

  Weeks 1-3

• EMA random prompt feasibility

  Weeks 1-3

Other Outcomes (2)

• Smoking reduction

  Week 3 vs. Week 1

• Complete switching to e-cigarettes

  Week 3

Study Arms (1)

E-cigarette arm

EXPERIMENTAL

Participants will receive the commercially available NJOY ACE e-cigarette, nicotine pods (2 of each available flavor, for a total of 4 pods), and tailored instructions to switch. Participants will use the ACE ad libitum for 14 days, reporting their cigarette use, e-cigarette use, mood, and nicotine crazing every day via text message surveys.

Device: NJOY ACE commercial e-cigarette

Interventions

NJOY ACE commercial e-cigarette DEVICE

The NJOY ACE is the commercial version of the Standardized Research E-Cigarette (SREC), which was developed by NIDA with NJOY for research purposes. Nicotine pods: * Sealed, pre-filled, non-refillable * 1.9 mL e-liquid with 5% w/w nicotine * Approx 300 (280-330) puffs/pod Nicotine liquid characteristics: * Volume of liquid per pod 1.9 mL * Active (nicotine USP 5% wt/wt) * 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

E-cigarette arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently engaged in outpatient treatment the Mathewson Institute (medication, behavioral, or combination treatment) or other local treatment center
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nevada, Reno: lead

Study Sites (1)

University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: June 18, 2024
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)