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Phase I Nicotinic Agonist Treatment Trial for Autism

Primary Purpose

Autism

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DMXB-A 150 mg
placebo
DMXB-A 75 mg
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Nicotinic agonist, Cognition, P50, Alpha 7

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DMXB-A 75 mg

DMXB-A 150 mg

Sugar Pill

Arm Description

DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level

DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level

placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 4, 2014
Last Updated
June 14, 2016
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02111551
Brief Title
Phase I Nicotinic Agonist Treatment Trial for Autism
Official Title
Phase I Nicotinic Agonist Treatment Trial for Autism
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
difficult to find participants and no funding
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autism, Nicotinic agonist, Cognition, P50, Alpha 7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DMXB-A 75 mg
Arm Type
Experimental
Arm Description
DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level
Arm Title
DMXB-A 150 mg
Arm Type
Experimental
Arm Description
DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind
Intervention Type
Drug
Intervention Name(s)
DMXB-A 150 mg
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
DMXB-A 75 mg
Primary Outcome Measure Information:
Title
Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration
Time Frame
2 hours after drug administration
Title
Difference between drug and placebo on the CPT at 30 minutes after administration
Time Frame
30 minutes after drug administration
Title
Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration
Time Frame
1 hour after drug administration
Title
Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration
Time Frame
2 hours after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Freedman, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18381905
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.
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Phase I Nicotinic Agonist Treatment Trial for Autism

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