Phase I Nicotinic Agonist Treatment Trial for Autism

University of Colorado Denver (CU Denver)

Status and phase: Terminated; Phase 1

Conditions: Autism

Treatments: Drug: DMXB-A 150 mg; Drug: DMXB-A 75 mg; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02111551

14-0614

Details and patient eligibility

About

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) .

Enrollment: 2 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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2 participants in 3 patient groups, including a placebo group

DMXB-A 75 mg

Experimental group

Description:

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

Treatment:

Drug: DMXB-A 150 mg

Other: placebo

DMXB-A 150 mg

Experimental group

Description:

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

Treatment:

Drug: DMXB-A 75 mg

Other: placebo

Sugar Pill

Placebo Comparator group

Description:

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

Treatment:

Drug: DMXB-A 75 mg

Drug: DMXB-A 150 mg