Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorPrisma Health-Upstate
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥21 years
Smoke ≥5 CPD for ≥1 year
Daily CC smoker
Willing to switch to EC
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Brief individual counseling sessions
BehavioralFive brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Sweet-Cooling EC + CounselingExperimental treatment 1 intervention
Group B: Sweet non-cooling EC + CounselingExperimental treatment 1 intervention
Group C: Tobacco-flavored EC + CounselingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
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 242
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 263
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 244
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 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Prisma Health-Upstate
Lead sponsor
Clemson University
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov