Clinical trial NCT02111551: Phase I Nicotinic Agonist Treatment Trial for Autism
Official title: Phase I Nicotinic Agonist Treatment Trial for Autism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Autism
Keywords: Autism
Nicotinic agonist
Cognition
P50
Alpha 7
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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) .


Eligibility 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

Primary outcomes:
measure: Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration
timeFrame: 2 hours after drug administration
measure: Difference between drug and placebo on the CPT at 30 minutes after administration
timeFrame: 30 minutes after drug administration
measure: Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration
timeFrame: 1 hour after drug administration
measure: Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration
timeFrame: 2 hours after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Robert Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.