ADHD
Conditions
Brief summary
This work will assess the prevalence in hard-to-treat ADHD of the ineffectiveness of the anesthetic Lidocaine.
Detailed description
Using a non-invasive, pain-free, taste-based approach to assess lidocaine effectiveness, the study will assess the frequency of ineffectiveness in the target population.
Interventions
DRUGLidocaine gel
Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg
Sponsors
NeurAbilities (formerly CRCNJ)
PhenoSolve, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
The scoring of the lidocaine test is masked, using the coded identity of the tastes. The tastes will be assessed in random order. The subjects and other study personnel will be told not to discuss what the subject could or couldn't taste. Scoring will not be shared with the testing site until all testing is complete. This is one of the last studies with an IRB for each arm and site. Hence it appears to be a single arm, but the other arms are separately registered with ClinicalTrials.gov
Intervention model description
Using a taste-based test before and after the application of lidocaine gel to the tongue, we will assess the degree to which lidocaine is effective at blocking taste in those with hard-to-treat ADHD
Eligibility
Sex/Gender
ALL
Age
7 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
ADHD
Exclusion criteria
for both arms: 1. known adverse reactions to lidocaine 2. epilepsy, IQ \<80, severe head trauma, birth weight \<2270 grams, and severe autism; 3. treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers; 4. generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness); 5. mouth sores; 6. Ehlers Danlos syndrome, and 7. red hair.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD | on day of testing, approximately 30 minutes for clinic visit | Subjects will be asked to identify each taste and its intensity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hard-to-treat ADHD Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Hard-to-treat ADHD |
|---|---|
| Age, Continuous | 16 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hard-to-treat ADHD (does not respond to available ADHD drugs) | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD
Subjects will be asked to identify each taste and its intensity.
Time frame: on day of testing, approximately 30 minutes for clinic visit
Population: Study population vs. previously published studies in pediatric populations (Nakai et al, 2000)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hard-to-treat ADHD | Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD | Lidocaine effective (got numb) | 1 Participants |
| Hard-to-treat ADHD | Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD | Lidocaine ineffective (did not get numb) | 27 Participants |