Phase I Nicotinic Agonist Treatment Trial for Autism

Phase 1

Terminated

• Conditions: Autism
• Interventions: Other: placebo; Drug: DMXB-A 150 mg; Drug: DMXB-A 75 mg

• Registration Number: NCT02111551
• Lead Sponsor: University of Colorado, Denver

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) .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-11
• Study Start: 2015-06
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DMXB-A 150 mg	placebo	DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level
DMXB-A 150 mg	DMXB-A 75 mg	DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level
DMXB-A 75 mg	DMXB-A 150 mg	DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level
DMXB-A 75 mg	placebo	DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level
Sugar Pill	DMXB-A 150 mg	placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind
Sugar Pill	DMXB-A 75 mg	placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind

Primary Outcome Measures

Name	Time	Method
Difference between drug and placebo on the CPT at 30 minutes after administration	30 minutes after drug administration
Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration	2 hours after drug administration
Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration	2 hours after drug administration
Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration	1 hour after drug administration

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States