Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment

• Combination Bupropion + NRTs (Drug)
• Extended Treatment (Other)
• Home Visits & Calls (Other)
• Monotherapy (Drug)

Primary outcomes

• Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM) [Measured week 0, 12, and 26]: Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent).

Sex: All, ages: 21 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Veterans 21 years of age or older;
2. meet DSM-IV criteria for Schizophrenia or Schizoaffective disorder based on clinical interview
3. meet DSM-IV criteria for nicotine dependence
4. must report smoking >10 cigarettes daily and positive CO exhalation >8ppm
5. seeking treatment for nicotine dependence;
6. willing and able to comply with study procedures;
7. willing and able to provide written informed consent;
8. if female, not pregnant or lactating and willing to use a medically reliable method of birth control during the trial (e.g., birth control pills, Depo-Provera, and/or condoms with spermicide).
9. Must be clinically stable (i.e., no inpatient hospitalizations for 3 months prior to enrollment, no changes in medication in the four weeks prior to enrollment)

Exclusion Criteria:

1. current or past history of cardiovascular disease including myocardial infarction, acute coronary syndrome, angina pectoris, coronary artery disease, atrial fibrillation/flutter, cor pulmonale, arrhythmia other than sinus tachycardia or sinus bradycardia, or an EKG suggesting any of these;
2. systolic blood pressure greater than 160 or diastolic blood pressure greater than 100 (i.e. cutoffs for stage 2 hypertension)
3. a history of angioedema;
4. renal impairment (CrCl < 50);
5. a current neurological disorder (e.g., organic brain disease, dementia) or a medical history which would make study agent compliance difficult or which would compromise informed consent;
6. a history of attempted suicide (lifetime) and/or suicidal ideation in the past year as assessed by the C-SSRS;
7. currently on prescription medication that is contraindicated for use with bupropion;
8. currently using any form of nicotine replacement therapy;
9. current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV within the past 6 months;
10. a history of sensitivity to bupropion or nicotine replacement;
11. any history of seizures or seizure disorder;
12. a history of serious head injury (ie, loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury
13. evidence of substance or alcohol dependence in the past six months; evidence of substance or alcohol abuse in the past month;
14. sedatives or benzodiazepine use within 12 hours of testing based on urine toxicology screening
15. history of mental retardation or developmental disability based on chart review
16. psychiatric hospitalization during study participation
17. history of an eating disorder
18. have a medical condition that could be made worse by treatment with nicotine, including poorly controlled insulin dependent diabetes, uncontrolled hyperthyroidism, pheochromocytoma, severe oropharyngeal, esophageal, or peptic ulcer disease, or severe renal or hepatic impairment as determined via the baseline medical history and physical exam
19. have an allergy to adhesive tape or latex or serious dermatologic disease (excluding minor skin conditions such as mild eczema) due to potential for skin allergy to patch
20. have a known allergy to nicotine or any component of the nicotine patches
21. be pregnant or sexually active and not using reliable birth control methods consistently (for females)

Participant flow

Outcome results

• Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM) (Primary), Mean, ppm: Standard Monotherapy 11.5 +/- 5.1; Combination Extended Treatment 12.3 +/- 9.9; Combination Extended Treatment + Home Visits/Calls 12.0 +/- 4.8

Adverse events

Time frame: For the 26 weeks the study was conducted.

Other adverse events by term

Limitations and caveats: Modest sample size lacked power to differentiate between the COMB-EXT groups with/without HV; no control group other than TAU; no motivation to quit rating scale; no biochemical (plasma, salivary, urine) measures taken to ensure abstinence