Nicotinic Receptors and Schizophrenia

VA Office of Research and Development

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Pharmacokinetic

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00952393

MHBB-005-09S

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pharmacokinetic

Other group

Description:

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

Treatment:

Drug: Pharmacokinetic