Electronic Cigarette Use, Nicotine Dependence
Conditions
Brief summary
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.
Detailed description
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks: baseline, 5 weekly check-in (CI) visits, and a 6-week assessment. Baseline assessments will include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment. All participants will attend weekly brief assessment check-in visits where distribution of either EC or NRT will occur. Check-in assessments will include cigarette use, EC use, NRT use, CO readings, respiratory symptoms, and tobacco demand. At the 6-week assessment, baseline measurements will be repeated to determine changes in the health effects, biomarkers, and combustible cigarette use associated with 6 weeks of EC use, relative to NRT. This study will be the first to test the potential behavioral and health effects of ECs in smokers with opioid use disorder, a population that is highly dependent on nicotine, highly vulnerable to smoking-related morbidity and mortality, and searching for novel methods to lower smoking-related risks.
Interventions
DRUGElectronic Cigarette
Electronic Cigarettes are provided to replace tobacco cigarettes
DRUGNicotine Lozenge
Nicotine Lozenges are provided to replace tobacco cigarettes
Sponsors
Butler Hospital
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* moderate to heavy cigarette smokers (10 cigarettes/day for \> 1 yr; breath CO \> 10 ppm) * have been receiving methadone for at least three months * attend at least weekly to receive methadone dose * speak English * have a telephone or access to a telephone * are available over the next 6 weeks * are interested in switching to either electronic cigarettes or nicotine replacement therapy
Exclusion criteria
* use of ECs on \> 2 of the past 30 days * currently use medications that may reduce smoking (e.g., bupropion, varenicline, NRT) * have unstable psychiatric conditions * have near-daily or daily use of marijuana * are pregnant * had a cardiovascular event in the last month * daily medication for asthma or COPD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NNAL | 6 weeks | urinary measure of NNAL |
| NNN | 6 weeks | Urinary measure of NNN |
| 3-HPMA | 6 weeks | Urinary measure of 3-HPMA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cigarettes Per Day | 6 weeks | Mean number of cigarettes per day assessed via the Timeline Followback over the last 6 weeks |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| 3-HPMA | 721.65 ng/mg STANDARD_DEVIATION 880.28 |
| Age, Continuous | 43.11 years STANDARD_DEVIATION 9.96 |
| cigarettes per day | 17.50 cigarettes per day STANDARD_DEVIATION 7.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| NNAL | .29 ng/mg STANDARD_DEVIATION 0.28 |
| NNN | .04 ng/mg STANDARD_DEVIATION 0.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 143 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 59 |
| other Total, other adverse events | 3 / 124 | 2 / 59 |
| serious Total, serious adverse events | 3 / 124 | 2 / 59 |
Outcome results
None listed