Phase I Nicotinic Agonist Treatment Trial for Autism
NCT02111551 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2016-06-16
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) .
Conditions
Interventions
- DRUG
-
DMXB-A 150 mg
- OTHER
-
placebo
- DRUG
-
DMXB-A 75 mg
Sponsors & Collaborators
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Robert Freedman, MD · University of Colorado, Denver
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2016-05-31
- Completion
- 2016-05-31
Countries
- United States
Study Locations
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