Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/2/2016 |
| Start Date: | August 2015 |
| End Date: | August 2019 |
| Contact: | Hanna Durand, MSN, RN |
| Email: | hanna.durand@uvm.edu |
| Phone: | 802-656-8859 |
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.
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.
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 for the past year,
3. Provide an intake breath CO sample >8 ppm, (if ≤ 8 ppm, then NicAlert Strip > 2)
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,,
8. Report no significant use of other tobacco or nicotine products within the past month
(more than 9 days in the past 30) and,
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 use 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 including:
1. Phenytoin [Brand Name: Dilantin]
2. Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]
3. Oxcarbazepine [Brand Name: Trileptal]
4. Primidone [Brand Name: Mysoline]
5. Phenobarbital
6. Positive toxicology screen for any of the following drugs: cocaine, illicit opiates,
benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
1. Marijuana will be tested for but will not be an exclusionary criterion.
Participants will be discouraged from smoking marijuana during the study.
2. Participants with valid prescriptions for opioids, benzodiazepines, barbiturates
or amphetamines will not be excluded.
3. Participants failing the toxicology screen will be allowed to re-screen once.
These participants will need to be re-consented before being rescreened to
ensure they have received adequate informed consent.
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
a. Participants failing the breath alcohol screen will be allowed to re-screen once.
These participants will need to be re-consented before being rescreened to ensure
they have received adequate informed consent.
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
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
a. Participants failing for heart rate 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,
15. Symptoms of psychosis or dementia,
16. Suicidal ideation in the past month (score > 0 on the BDI question 9 or endorse
question 3, 4 and/or 5 on the MINI suicide subscale),
17. Suicide attempt in past ten years (endorse question 6 on the MINI suicide subscale
with suicide attempt in the past 10 years) or,
18. Participation in another smoking research study in the past 90 days.
We found this trial at
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sites
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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