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

NCT02676375 | Completed Phase 4 Results

• 1 other identifier: 0024
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Standard Monotherapy

OTHER

Treatment as usual starting with one smoking cessation medication plus group therapy.

Drug: Monotherapy

Combination Extended Treatment

EXPERIMENTAL

Extended treatment with multiple standard medications plus group therapy.

Drug: Combination Bupropion + NRTs; Other: Extended Treatment

Combination Extended Treatment + Home Visits/Calls

EXPERIMENTAL

Extended treatment with multiple standard medications plus group therapy plus home visits.

Drug: Combination Bupropion + NRTs; Other: Extended Treatment; Other: Home Visits & Calls

Interventions

Combination Bupropion + NRTs DRUG

Combination Extended Treatment; Combination Extended Treatment + Home Visits/Calls

Extended Treatment OTHER

Combination Extended Treatment; Combination Extended Treatment + Home Visits/Calls

Home Visits & Calls OTHER

Combination Extended Treatment + Home Visits/Calls

Monotherapy DRUG

Standard Monotherapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans 21 years of age or older;
• meet DSM-IV criteria for Schizophrenia or Schizoaffective disorder based on clinical interview
• meet DSM-IV criteria for nicotine dependence
• must report smoking \>10 cigarettes daily and positive CO exhalation \>8ppm
• seeking treatment for nicotine dependence;
• willing and able to comply with study procedures;
• willing and able to provide written informed consent;
• 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).
• 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)

You may not qualify if:

• 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;
• systolic blood pressure greater than 160 or diastolic blood pressure greater than 100 (i.e. cutoffs for stage 2 hypertension)
• a history of angioedema;
• renal impairment (CrCl \< 50);
• 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;
• a history of attempted suicide (lifetime) and/or suicidal ideation in the past year as assessed by the C-SSRS;
• currently on prescription medication that is contraindicated for use with bupropion;
• currently using any form of nicotine replacement therapy;
• current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV within the past 6 months;
• a history of sensitivity to bupropion or nicotine replacement;
• any history of seizures or seizure disorder;
• a history of serious head injury (ie, loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury
• evidence of substance or alcohol dependence in the past six months; evidence of substance or alcohol abuse in the past month;
• sedatives or benzodiazepine use within 12 hours of testing based on urine toxicology screening
• history of mental retardation or developmental disability based on chart review

Sponsors & Collaborators

• Brentwood Biomedical Research Institute: lead

Study Sites (1)

West Los Angeles Veterans Affairs Medical Center

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Schizophrenia

Interventions

House Calls

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

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

Results Point of Contact

• Title: Dr. Arthur Brody
• Organization: Department of Psychiatry, University of California San Diego

abrody@ucsd.edu

8585528585

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 8, 2016
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 30, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)