P2S2: Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
Study Details
Study Description
Brief Summary
This study will examine extended exposure to cigarettes varying in nicotine content among opioid abusers. Prevalence of smoking among opioid-dependent adults far exceeds that of the general US adult population. Opioid-dependent smokers are also at elevated risk for smoking-related adverse health effects. 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 opioid abusers 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 0.8 mg nicotine 0.8 mg nicotine very low nicotine content cigarettes |
Other: Very low nicotine content cigarettes
Very low nicotine content cigarettes
|
Experimental: 0.12 mg nicotine 0.12 mg nicotine very low nicotine content cigarettes |
Other: Very low nicotine content cigarettes
Very low nicotine content cigarettes
|
Experimental: 0.03 mg nicotine 0.03 mg nicotine very low nicotine content cigarettes |
Other: Very low nicotine content cigarettes
Very low nicotine content cigarettes
|
Outcome Measures
Primary Outcome Measures
- Cigarettes per day [12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women ages 18-70, who are currently receiving methadone or buprenorphine maintenance treatment for opioid dependence.
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Report smoking ≥ 5 cigarettes per day.
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Provide an intake breath CO sample >8 ppm.
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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.
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Be sufficiently literate to complete the research-related tasks.
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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.
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Not pregnant or nursing, and report using oral, implant, injection or barrier contraceptives, or report being surgically sterile, or post menopausal.
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Report no significant use of other tobacco or nicotine products within the past month (more than 9 days in the past 30).
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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).
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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.
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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:
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Any prior regular use (used as primary cigarette outside of laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content).
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Exclusive use of roll-your-own cigarettes.
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Planning to quit smoking in the next 30 days.
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A quit attempt in the past 30 days resulting in greater than 3 days of abstinence.
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Currently taking anticonvulsant medications.
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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).
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Not currently enrolled in a treatment program for opioid dependence and/or not currently stable on their methadone or buprenorphine dose.
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Breath alcohol level > 0.01 ( participants with a positive screen will be allowed to re-screen once).
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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),
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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).
- Participants failing for blood pressure will be allowed to re-screen once.
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Breath CO > 80 ppm.
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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).
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Currently seeking treatment for smoking cessation.
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Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression).
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Current symptoms of psychosis or dementia, or mania.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Johns Hopkins University | Baltimore | Maryland | United States | 21224 |
2 | University of Vermont | Burlington | Vermont | United States | 05401 |
Sponsors and Collaborators
- University of Vermont
- National Institute on Drug Abuse (NIDA)
- Johns Hopkins University
Investigators
- Study Director: Stephen T. Higgins, Ph.D., University of Vermont
- Principal Investigator: Stacey Sigmon, Ph.D., University of Vermont
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P50DA036114:P2S2
- P50DA036114