Novel Smoking Cessation Drug for Schizophrenia

• Status: Completed
• Trial end date: 2017-03-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: K.N. Roy Chengappa
• Collaborators: National Institutes of Health (NIH); University of Pittsburgh; Virginia Commonwealth University

Criteria

Inclusion Criteria: List the specific criteria for inclusion of potential subjects.

• 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

Smoking Inclusion Criteria:

• Smoke ≥ 5 cigarettes/day

• Smoking cigarettes ≥ 1 year

Exclusion Criteria:

Smoking/Nicotine Exclusions:

• 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)

Alcohol/Illicit Substance Exclusion Criteria:

• Recent alcohol or substance dependence (≤ 3 months)

• Current alcohol consumption that exceeds 15 standard drinks/week or greater than 2 standard drinks daily

Medical Exclusion Criteria:

• 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.

• Any clinically significant hematological laboratory abnormality (chronic low-grade laboratory values just above or below the reference range that are without clinical significance will be permitted) will be grounds for exclusion.

Medication Exclusion Criteria:

• Current use or recent discontinuation (within last 14-days) of the following medications: any form of smoking cessation medication (Bupropion except when used for Depressive Disorders on a case by case basis, Varenicline, NRT); and (b) opiate-containing medications for chronic pain. Potent CYP 3A4 inhibitors will be reviewed for exclusion, see below.

• 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.

• Stable medical conditions examples: hypertension, diabetes, dyslipidemia etc that are treated and ongoing and patients are not receiving the exclusionary drugs noted above will be considered for inclusion on a case by case basis.