Phase I Nicotinic Agonist Treatment Trial for Autism

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Autism

In brief

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) .

Key facts

Study ID: NCT02111551
Run by: University of Colorado, Denver
People needed: 2
Starts: 2015-06-01
Expected to finish: 2016-05-01
Last updated by the study team: 2016-06-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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