Phase 2
N=775
Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02250664 ↗Enrolled (actual)
775
Serious AEs
3.9%
Results posted
Dec 2022
Primary outcome: Primary: Cigarettes Per Day (CPD) — 25.28; 19.95; 17.74 cigarettes per day — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Very low nicotine content cigarettes (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarettes Per Day (CPD) |
25.28; 19.95; 17.74 | <0.0001 sig |
Summary
This study will examine extended exposure to cigarettes varying in nicotine content among adults with opioid use disorder. Those with opioid use disorder are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including site specific cancers, heart disease, and premature death. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like those with opioid use disorder who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.
Eligibility Criteria
Inclusion Criteria
- Men and women ages 18-70, who are currently receiving methadone or buprenorphine maintenance treatment for opioid dependence.
- Report smoking ≥ 5 cigarettes per day.
- Provide an intake breath carbon monoxide (CO) sample >8 ppm.
- Be without current (within the past year) serious mental disorder that would interfere with study results or completion as determined by the licensed medical professional or PI.
- Be sufficiently literate to complete the research-related tasks.
- Be in good physical health without serious illness or change in health or medication (not including methadone or buprenorphine dose) in the past three months as determined by the license medical professional at each site.
- Not pregnant or nursing, and report using oral, implant, injection or barrier contraceptives, or report being surgically sterile, or post menopausal.
- Report no significant use of other tobacco or nicotine products within the past month (more than 9 days in the past 30).
- Participants must be maintained on a stable methadone or buprenorphine dose for the past month, with no evidence of regular illicit-drug abuse ( 0.01 ( participants with a positive screen will be allowed to re-screen once).
- Self-report of binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period in females/males),
- Blood pressure is greater than or equal to 160/100 mmHg or below 90/50 mmHg (participants outside the range will be allowed to re-screen once).
a. Participants failing for blood pressure will be allowed to re-screen once.
- Breath CO > 80 ppm.
- Heart rate is greater than or equal to 115 bpm or less than 45 bpm ( participants outside the range will be allowed to re-screen once).
- Currently seeking treatment for smoking cessation.
- Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression).
- Current symptoms of psychosis or dementia, or mania.
- Suicidal ideation in the past month. 17.) Suicide attempt in the past 6 months. 18.) Participation in another research study in the past 30 days.
Data sourced from ClinicalTrials.gov (NCT02250664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.