The Effects of Nicotine on Cognition in Schizophrenia

NCT00383747 | Completed Phase 4 Results

• 2 other identifiers: 04T574CORRC 07-2004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with schizophrenia have a variety cognitive deficits and nicotine has been shown to normalize some of these deficits. The purpose of this study is to investigate the effects of nicotine on cognition in schizophrenia.We will evaluate the effects of transdermal nicotine compared with placebo for attentional impairments in non-smokers with schizophrenia and controls.

Conditions

Schizophrenia

Keywords

cognition; nicotine; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version

  The primary outcome measure was attention as measured by the Continuous Performance Test Identical Pairs (CPT-IP) Version 4.0 (Biobehavioral Technologies, New York, USA), developed for use in patients with schizophrenia and normal controls. In this task, participants were asked to respond when two identical pairs of numbers were presented in sequence by pressing a mouse key as quickly as possible using the dominant hand.The stimuli were presented with increasing cognitive load in successive blocks: two-,three- and four-digit target in the first, second and third block, respectively. Hit reaction time, a standard outcome variables on the CPTIP, is presented here. It was measured 3 hrs after application of the patch

  Visit 1 and visit 2 (separated by an interval of 7-10 days)

Secondary Outcomes (3)

• Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Visual Attention and Cognitive Interference as Measured by Three Card Stroop

  Visit 1 and visit 2 (separated by an interval of 7-10 days)

• Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing

  Visit 1 and visit 2 (separated by an interval of 7-10 days)

• Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Lateralized Psychomotor Speed Measured by the Grooved Pegboard

  Visit 1 and visit 2 (separated by an interval of 7-10 days)

Study Arms (2)

Nicotine Patch

ACTIVE COMPARATOR

Drug: transdermal nicotine patch

Placebo Nicotine Patch

PLACEBO COMPARATOR

Drug: Transdermal Nicotine Patch

Interventions

Transdermal Nicotine Patch DRUG

14mg transdermal nicotine application

Also known as: Nicoderm CQ patch

Nicotine Patch

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients:
• DSM IV diagnosis of schizophrenia,
• age 18 - 60 inclusive,
• able to provide informed consent,
• treated with antipsychotic medications at a stable dose for at least 4 weeks,
• not treated with an investigational medication in the past 30 days,
• WRAT-3 IQ raw score greater than or equal to 35,
• non smokers for more than 3 months\*,
• normal or corrected to normal vision.
• Non Smoking defined by:
• Self report of not smoking a single cigarette in the past 3 months.
• Salivary Cotinine level \< 30 ng/ml at screening and on the day of testing
• Expired air CO \< 9ppm on the day of the testing
• Control Group:
• Age 18 - 60 inclusive,

You may not qualify if:

• Patients:
• Use of any nicotine containing product in the past 3 months by self report,
• use of cholinesterase inhibitors such as galantamine in the past 3 months,
• untreated ischaemic heart disease,
• uncontrolled hypertension,
• current unstable serious medical illness (renal, neoplastic, hematological),
• allergy to patches.
• Currently or planning to be pregnant in the next 8 weeks, as verified by positive pregnancy test, or childbearing potential and not using adequate contraception. Those not of childbearing potential include post-menopausal, surgically sterilized, and male participants.
• Substance abuse in the past month: self-reported, diagnosed during chart review, and verified by a positive salivary test for cotinine, cocaine, methamphetamine, amphetamine, ethanol, TCH, opiates or PCP at screen.
• Recent deterioration in mental state, current major depressive disorder, history of cognitive impairment secondary to other disorders such as head injury, dementia, general medical condition, diagnosis of mental retardation
• Controls:
• Past or present DSM IV diagnosis of schizophrenia, schizoaffective disorder, major depression, bipolar disorder, or mental retardation.
• First degree relative with diagnosis of schizophrenia or schizoaffective disorder,
• use of cholinesterase inhibitors such as galantamine in the past 3 months,
• untreated ischaemic heart disease,

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Stanley Medical Research Institute: collaborator
• North Suffolk Mental Health Association: collaborator

Study Sites (1)

Massachusetts General Hospital Schizophrenia Research Program

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• Barr RS, Culhane MA, Jubelt LE, Mufti RS, Dyer MA, Weiss AP, Deckersbach T, Kelly JF, Freudenreich O, Goff DC, Evins AE. The effects of transdermal nicotine on cognition in nonsmokers with schizophrenia and nonpsychiatric controls. Neuropsychopharmacology. 2008 Feb;33(3):480-90. doi: 10.1038/sj.npp.1301423. Epub 2007 Apr 18.

  PMID: 17443126 RESULT

• Barr RS, Pizzagalli DA, Culhane MA, Goff DC, Evins AE. A single dose of nicotine enhances reward responsiveness in nonsmokers: implications for development of dependence. Biol Psychiatry. 2008 Jun 1;63(11):1061-5. doi: 10.1016/j.biopsych.2007.09.015. Epub 2007 Nov 5.

  PMID: 17976537 RESULT

• Jubelt LE, Barr RS, Goff DC, Logvinenko T, Weiss AP, Evins AE. Effects of transdermal nicotine on episodic memory in non-smokers with and without schizophrenia. Psychopharmacology (Berl). 2008 Jul;199(1):89-98. doi: 10.1007/s00213-008-1133-8. Epub 2008 Jun 12.

  PMID: 18548234 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: A. Eden Evins, MD, MPH. Director of the MGH-Harvard Center for Addiction Medicine
• Organization: Massachusetts General Hospital - Harvard Medical School

a_eden_evins@hms.harvard.edu

6176434679

Study Officials

• A E EVINS, MD MPH

  Massachusetts General Hosptal

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: April 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-03

Locations

US (1)