Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Schizophrenia, Smoking Cessation |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
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.
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.
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)
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