Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers (P2S2)

This is an interventional basic science trial for Tobacco Use Disorder focused on measuring Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal, Women, Health disparities, Vulnerable populations Read More

Inclusion Criteria:

1. Men and women ages 18-70, who are currently receiving methadone or buprenorphine maintenance treatment for opioid dependence.
2. Report smoking ≥ 5 cigarettes per day.
3. Provide an intake breath CO sample >8 ppm.
4. 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.
5. Be sufficiently literate to complete the research-related tasks.
6. 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.
7. Not pregnant or nursing, and report using oral, implant, injection or barrier contraceptives, or report being surgically sterile, or post menopausal.
8. Report no significant use of other tobacco or nicotine products within the past month (more than 9 days in the past 30).

9. Participants must be maintained on a stable methadone or buprenorphine dose for the past month, with no evidence of regular illicit-drug abuse (<30% positive specimens in the past 30 days).

   1. Consent to confirm dose and drug abstinence with the participant's opioid clinic will be obtained at screening and we will monitor any changes in dose throughout the study.
   2. Participants must provide at least three urine samples within the last 30 days. If they do not have three they will be asked to come in and provide a sample. They may leave up to two samples per week with at least one full day between samples.

Exclusion Criteria:

1. Any prior regular use (used as primary cigarette outside of laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content).
2. Exclusive use of roll-your-own cigarettes.
3. Planning to quit smoking in the next 30 days.
4. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence.
5. Currently taking anticonvulsant medications.
6. Positive toxicology screen for illicit drugs not including Marijuana ( participants with valid prescriptions will not be excluded and participants with a positive toxicology screen will be allowed to re-screen once).
7. Not currently enrolled in a treatment program for opioid dependence and/or not currently stable on their methadone or buprenorphine dose.
8. Breath alcohol level > 0.01 ( participants with a positive screen will be allowed to re-screen once).
9. 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),

10. 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.

11. Breath CO > 80 ppm.
12. 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).
13. Currently seeking treatment for smoking cessation.
14. Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression).
15. Current symptoms of psychosis or dementia, or mania.
16. 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.