Phase I Nicotinic Agonist Treatment Trial for Autism

June 14, 2016 updated by: University of Colorado, Denver
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) .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DMXB-A 75 mg
DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level
Other: placebo
Drug: DMXB-A 150 mg
Experimental: DMXB-A 150 mg
DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level
Other: placebo
Drug: DMXB-A 75 mg
Placebo Comparator: Sugar Pill
placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind
Drug: DMXB-A 150 mg
Drug: DMXB-A 75 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 hours after drug administration
Difference between drug and placebo on the CPT at 30 minutes after administration
Time Frame: 30 minutes after drug administration
30 minutes after drug administration
Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration
Time Frame: 1 hour after drug administration
1 hour after drug administration
Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration
Time Frame: 2 hours after drug administration
2 hours after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Robert Freedman, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0614

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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