Phase I Nicotinic Agonist Treatment Trial for Autism
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | August 2018 |
| Contact: | Ann Olincy, MD |
| Email: | ann.olincy@ucdenver.edu |
| Phone: | 303 724 6209 |
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 EEG .
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 EEG .
Inclusion Criteria:
- age 18-50
- meet DSM-5 criteria for Autism Spectrum Disorder, Levels 1 or 2, as defined by Autism
Diagnostic Observation Schedule
- non-smoking persons
- in good health
Exclusion Criteria:
- persons with estimated verbal and nonverbal IQ < 70.
- abuse of other substances.
- Persons not sufficiently fluent in English to permit testing
- those with history of severe head injury
- Fragile X Syndrome
- Rett Syndrome
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Robert Freedman, MD
Phone: 303-724-6209
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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