Phase I Nicotinic Agonist Treatment Trial for Autism

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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) .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: 3-(2,4-dimethoxybenzylidene)anabaseine; Nicotinic Agonists

Criteria

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