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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Schizophrenia
• Intervention / Treatment: Drug: Monotherapy; Drug: Combination Bupropion + NRTs; Other: Extended Treatment; Other: Home Visits & Calls

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • West Los Angeles Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard Monotherapy; Treatment as usual starting with one smoking cessation medication plus group therapy.	Drug: Monotherapy
Experimental: Combination Extended Treatment; Extended treatment with multiple standard medications plus group therapy.	Drug: Combination Bupropion + NRTs; Other: Extended Treatment
Experimental: Combination Extended Treatment + Home Visits/Calls; Extended treatment with multiple standard medications plus group therapy plus home visits.	Drug: Combination Bupropion + NRTs; Other: Extended Treatment; Other: Home Visits & Calls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM)	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).	Measured week 0, 12, and 26

Collaborators and Investigators

• Sponsor: Brentwood Biomedical Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: 0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO