Nicotinic Receptors and Schizophrenia
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00952393
First received: August 3, 2009
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: 3-2,4 dimethoxbenzylidene anabaseine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Nicotinic Receptors and Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Blood levels of drug [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1 |
Drug: 3-2,4 dimethoxbenzylidene anabaseine
nicotinic agonist
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952393
Locations
| United States, Colorado | |
| VA Eastern Colorado Health Care System, Denver | |
| Denver, Colorado, United States, 80220 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Robert Freedman, MD | VA Eastern Colorado Health Care System, Denver |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00952393 History of Changes |
| Other Study ID Numbers: | MHBB-006-09S |
| Study First Received: | August 3, 2009 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
receptors nicotinic |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013