Nicotinic Receptors and Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Pharmacokinetic

• Registration Number: NCT00952393
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.

Detailed Description

3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.

Study Timeline

• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Study Start: 2010-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-11-25
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-06
• Last Update Submitted: 2016-01-06
• Results First Posted: 2016-02-05
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Healthy volunteers: males and females who are incapable of pregnancy

Exclusion Criteria

• Medical illnesses requiring acute treatment
• History of seizures
• Substance abuse including nicotine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetic	Pharmacokinetic	This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.

Primary Outcome Measures

Name	Time	Method
Blood Levels of Drug	12 hours	This is the plasma level of the drug as determined by high performance liquid chromatography.

Trial Locations

Locations (1)

VA Eastern Colorado Health Care System, Denver; 🇺🇸 Denver, Colorado, United States