Novel Smoking Cessation Drug for Schizophrenia

NCT02230384 | Completed Phase 2 Results DMC

• 2 other identifiers: PRO14060338UH3TR000958
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will evaluate effects of a novel drug that improves nicotinergic receptor function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have a high interest in quitting. The investigators predict that the novel drug will increase days of abstinence, compared with placebo, identifying potential evidence of efficacy for smoking cessation in smokers with schizophrenia. The investigators will also assess if this new drug decreases nicotine withdrawal, craving, and cognitive impairment during early abstinence, as well as evaluate adverse effects.

Conditions

Smoking Cessation

Keywords

Attempt at Smoking Cessation; Schizophrenia or Schizoaffective disorder; Novel nicotinergic drug

Outcome Measures

Primary Outcomes (1)

• Quit Status

  Complete abstinence from smoking for 24 hr, assessed daily from Mon-Fri for just one week. This same Mon-Fri procedure for one week (only) is done for both drug phases (Number of days abstinent per each quit week) Numbers reported are collapsed across medication conditions for each medication order.

  Daily - Mon-Fri during the quit week in each phase

Secondary Outcomes (6)

• Withdrawal When Quit

  during each quit week

• Cognitive Functions

  Assessed at the end of both treatment phases, i.e., at the end of 3 and 6 weeks.

• Monitoring of Psychiatric Symptoms Including Psychopathology

  Once at every scheduled visit

• Number of Participants That Met Criteria for Treatment Emergent Suicidal Ideation or Behavior

  Every visit up to six weeks. It is only significant when there is a positive response "Yes"

• Number of Participants That Had Treatment Emergent Clinically Significant Abnormal Lab Results

  Weeks 0, 2, 3, 5, 6

Study Arms (2)

Active JNJ Drug

EXPERIMENTAL

200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.

Drug: Active JNJ Drug; Drug: Placebo Pill

Placebo Pill

EXPERIMENTAL

Placebo pill used for one week quit attempt, as part of crossover design.

Drug: Active JNJ Drug; Drug: Placebo Pill

Interventions

Active JNJ Drug DRUG

200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week

Also known as: JNJ-39393406

Active JNJ Drug; Placebo Pill

Placebo Pill DRUG

Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week

Active JNJ Drug; Placebo Pill

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women of any race, ages 18 to 65 years, (≥18 years, ≤ 66 years)
• Willing to provide written informed consent
• MINI (Sheehan et al 1998, 2008) chart and/or clinician consensus affirmed DSM IV TR or (DSM -V) diagnoses of schizophrenia or schizoaffective disorder.
• Patients whose PANSS total scores have been stable for ≥ 4 weeks (clinician and/or subject affirmed) and at ≤ 70
• No recent ( ≤ 3months) hospitalization, aggression, or suicidal attempts
• Stable doses of antipsychotic medication, ≥ 4 weeks
• Smoke ≥ 5 cigarettes/day
• Smoking cigarettes ≥ 1 year

You may not qualify if:

• Use of smokeless tobacco or snuff or chewing tobacco
• Use of e-cigarettes, or any non-tobacco nicotine products (e.g. nicotine gum, lozenges, patch, etc.)
• Current enrollment or plans to enroll in another smoking cessation program. (Bupropion use for depression will be assessed on a case by case basis)
• Recent alcohol or substance dependence (≤ 3 months)
• Current alcohol consumption that exceeds 15 standard drinks/week or greater than 2 standard drinks daily
• Women who are pregnant, planning a pregnancy, or lactating; all female participants shall undergo a pregnancy test at screening and will be excluded if positive.
• Serious or unstable medical disorder within the past 3 months (assessed by the investigators)
• Epilepsy
• Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months
• Evidence impaired liver function test (LFT) defined as serum glutamate oxaloacetate transaminase (SGOT) (AST) or serum glutamate pyruvate transaminase (SGPT) (ALT) or alkaline phosphatase greater than 1x the upper limit of normal, or bilirubin 1x the upper limit of normal
• Evidence of kidney failure defined as: Serum creatinine \> 1.8 mg/dl for males and 1.6 mg/dl for females.
• Any subject with a history of hematological cancers examples: leukemia, lymphoma etc. will be excluded.
• In view of novel drug being a moderate CYP3A4 inhibitor, any subjects receiving the following narrow therapeutic index CYP3A4 substrates will be excluded: Alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine.
• In view of the impact of clozapine on smoking cessation, patients receiving clozapine will be excluded.

Sponsors & Collaborators

• K.N. Roy Chengappa: lead
• University of Pittsburgh: collaborator
• National Institutes of Health (NIH): collaborator
• Virginia Commonwealth University: collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic and affilated sites

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Schizophrenia; Psychotic Disorders

Interventions

JNJ-39393406

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: K.N. Roy Chengappa, MD / Principal Investigator
• Organization: University of Pittsburgh

chengappakn@upmc.edu

412-246-5006

Study Officials

• K.N. Roy Chengappa, MD

  Western Psychiatric Institute and Clinic - UPMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: September 3, 2014
• Study Start: September 1, 2014
• Primary Completion: December 16, 2016
• Study Completion: March 9, 2017
• Last Updated: April 2, 2019
• Results First Posted: January 30, 2018

Record last verified: 2019-03

Locations

US (1)