MedDataX Logo

Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors

NCT ID: NCT00802919

Last Updated: 2017-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a) measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes. Subjects will be current cigarette smokers or history of regular smokers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a double-blind placebo controlled study of varenicline and matched placebo in patients with a diagnosis of schizophrenia or schizoaffective psychosis who were treated with antipsychotic medication and were cigarette smokers. Three sites (2 U.S., 1 Israel) were supported by the Stanley grant. A similar independently supported study was conducted in Beijing, China. We were allowed to access these data and combine them for our analysis of results. Subjects at each site participated in a protocol which was approved by their institutional IRB. All subjects signed informed consent.

The study evaluated multiple measures of cigarette smoking, cognitive functions by MATRICS battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia), and psychiatric symptoms by PANSS (Positive and Negative Symptom Scale), SANS (Schedule For Assessment Of Negative Symptoms), and Calgary Depression scales. Lymphocytes were collected for measurement of epigenetically related mRNA's.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Cigarette Smoking

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

schizophrenia smoking nicotine cognitive deficits nicotinic receptors Cognitive Deficits in Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Varenicline

Varenciline 1-2 mg/day

Group Type EXPERIMENTAL

Varenicline

Intervention Type DRUG

Varenicline 1-2 mg/day

Matched Placebo

placebo for varenicline

Group Type PLACEBO_COMPARATOR

Placebo for varenicline

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Varenicline

Varenicline 1-2 mg/day

Intervention Type DRUG

Placebo for varenicline

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Chantix

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication

Exclusion Criteria

prior history of hospitalization for acute myocardial infarction or stroke, or persistent angina pectoris with current symptoms Patients who have previously tried varenicline and have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt in the last year and or have had prominent or serious suicidal thoughts in the past year Women who are pregnant, nursing, or unable to use reliable contraception significant renal impairment(Creatinine ≥ 1.5) baseline Hamilton Depression Scores is \>20
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robert C. Smith MD PhD

Research Psychiatrist, Principal Investigagtor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert C. Smith, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nathan Kline Institute for Psychiatric Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Manhattan Psychatirc Center

New York, New York, United States

Site Status

Nathan Kline Insitute for Psychiatric Research

Orangeburg, New York, United States

Site Status

Peking University Institute of Mental Health

Beijing, , China

Site Status

The Division of Psychiatry, Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States China Israel

References

Explore related publications, articles, or registry entries linked to this study.

Smith RC, Amiaz R, Si TM, Maayan L, Jin H, Boules S, Sershen H, Li C, Ren J, Liu Y, Youseff M, Lajtha A, Guidotti A, Weiser M, Davis JM. Varenicline Effects on Smoking, Cognition, and Psychiatric Symptoms in Schizophrenia: A Double-Blind Randomized Trial. PLoS One. 2016 Jan 5;11(1):e0143490. doi: 10.1371/journal.pone.0143490. eCollection 2016.

Reference Type BACKGROUND
PMID: 26730716 (View on PubMed)

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type DERIVED
PMID: 37142273 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FDA IND 102,411

Identifier Type: -

Identifier Source: secondary_id

081/C02

Identifier Type: -

Identifier Source: org_study_id