Recruiting

Varenicline

Sponsor:

Corporal Michael J. Crescenz VA Medical Center

Code:

NCT03495024

Conditions

Schizophrenia

Schizoaffective Disorder

Tobacco Smoking

Tardive Dyskinesia

Parkinsonism

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Varenicline

Study Details

Brief summary:

To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.

Conditions

Schizophrenia

Schizoaffective Disorder

Tobacco Smoking

Tardive Dyskinesia

Parkinsonism

Study ID

NCT03495024

Start date

Jan 1, 2019

Status verified date

Mar, 2019

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Apr 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • DSM 5 criteria for schizophrenia or schizoaffective disorder and stable disease
  • Glazer-Morgenstern-Doucette criteria for TD
  • Smoking at least 5 cigarettes on average daily for at least 30 days prior to screening
  • An exhaled carbon monoxide concentration greater than 5 parts per million (ppm) at screening
  • Agree to stop smoking by the target date (four weeks after baseline
  • Concurrence for varenicline treatment from the patient's mental health provider if the patient is under mental health care; OR, if the patient is not under mental health care, the prescribing clinician should consult with a mental health provider to evaluate the patient for appropriateness to receive varenicline

Exclusion Criteria:

  • Have untreated or unstable acute medical or psychiatric illnesses
  • Have a history of seizures
  • History of somnambulism
  • Have chronic degenerative neurological illnesses (e.g., Parkinson's disease)
  • Have a history of active substance abuse (including marijuana abuse) in the 3 months prior to screening or a positive toxicology screen
  • Are receiving clozapine or cholinesterase inhibitors
  • Had a change in dosing or medication type of antipsychotic or anti-muscarinic for one month prior to enrollment (two months for long-acting antipsychotics)
  • Are unable to remain on a stable dose of antipsychotic or anti-muscarinic during the study period
  • Have acute suicidal ideation, intent or behavior within 12 months or risk based assessed on the C-SSRS or depression/anxiety score ≥ 8 on the HADS.
  • Female subjects of childbearing age will have a negative pregnancy serum test at screening and are required to use approved methods of birth control
  • Use of an investigational drug within 30 days of screening
  • Use of other smoking cessation aids (bupropion, nicotine replacement products)
  • Use of other tobacco products
  • History of allergic reactions to varenicline
  • Lack capacity to provide informed consent

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Smoking cessation with varenicline

FDA-approved indication of varenicline for smoking cessation

Interventions

Varenicline

Oral medication approved to facilitate smoking cessation

Primary outcome measure

  • Self-reported 7-day point prevalence of abstinence prior to week 12 [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Stanley N Caroff, MD

215-823-4065stanley.caroff@va.gov

Rosalind M Berkowitz, MD

215-823-4065rosalind.berkowitz@va.gov

Locations

Corporal Michael J Crescenz VA Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Stanley N Caroff, MD

215-823-4065stanley.caroff@va.gov

Rosalind M Berkowitz, MD

215-823-4065rosalind.berkowitz@va.gov

More Information

Sponsor

Corporal Michael J. Crescenz VA Medical Center

Last update posted

Mar 22, 2019

Last verified

Mar, 2019

Keywords

  • Schizophrenia
  • Schizoaffective disorder
  • Antipsychotics
  • Tobacco smoking
  • Tardive dyskinesia
  • Parkinsonism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Corporal Michael J. Crescenz VA Medical Center on 2019-03-22.