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difficult to find participants and no funding
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This study plans to learn more about whether a nicotine-like investigational new drug, DMXB-A [3-(2,4-dimethoxybenzylidene) anabaseine] may have positive effects on mental focus and may help us to find new types of treatment for autism spectrum disorder. Subjects will come in for a screening visit and three more drug visits. There will be at least one week between each drug visit to allow the drug to be eliminated from your system completely. During each drug visit subjects will receive either a placebo (a capsule that looks like medicine but is not real), 75 mg of DMXB-A, or 150 mg of DMXB-A. During the drug day vital signs and well being will be monitored by the study physician. Subjects will complete some paper and pencil tasks to test memory, attention, speed, and problem solving, some rating scales and questionnaires, and the study team will record brain wave patterns with an electroencephalogram (EEG) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMXB-A 75 mg | Experimental | DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level |
|
| DMXB-A 150 mg | Experimental | DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level |
|
| Sugar Pill | Placebo Comparator | placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMXB-A 150 mg | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration | 2 hours after drug administration | |
| Difference between drug and placebo on the CPT at 30 minutes after administration | 30 minutes after drug administration | |
| Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration | 1 hour after drug administration | |
| Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration | 2 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Freedman, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18381905 | Background | Freedman R, Olincy A, Buchanan RW, Harris JG, Gold JM, Johnson L, Allensworth D, Guzman-Bonilla A, Clement B, Ball MP, Kutnick J, Pender V, Martin LF, Stevens KE, Wagner BD, Zerbe GO, Soti F, Kem WR. Initial phase 2 trial of a nicotinic agonist in schizophrenia. Am J Psychiatry. 2008 Aug;165(8):1040-7. doi: 10.1176/appi.ajp.2008.07071135. Epub 2008 Apr 1. |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C088936 | 3-(2,4-dimethoxybenzylidene)anabaseine |
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| DMXB-A 75 mg | Drug |
|