Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment
Condition: Smoking Cessation; Schizophrenia
MeSH terms: Schizophrenia
Intervention: Combination Bupropion + NRTs; Extended Treatment; Home Visits & Calls; Monotherapy
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic
      and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into
      three arms of treatment for smoking cessation treatment, receiving either 1. Control:
      "standard therapy" (n=15), including stepwise monotherapy of nicotine patch or bupropion
      sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and
      nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion,
      nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to
      the home or living facility. During all treatments, participants will receive weekly smoking
      cessation group counseling, as is standard for smoking cessation treatment. At the time of
      enrollment, participants will complete a one-study visit lead-in to complete baseline
      assessments, psychological and medical evaluation, and comprehensive assessment of drug use
      to determine study eligibility. Once determined to be eligible for the trial, participants
      will be randomly assigned to one of the treatment arms using a randomization procedure. The
      "standard therapy" treatment arm, or control group, will receive either nicotine patch taper
      starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained
      release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The
      extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine
      lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg
      daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6
      months (as tolerated). The third arm will be identical to the second arm except for the added
      home visit intervention.
    

Eligibility criteria:

        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)