ADHD, PMS
Conditions
Brief summary
This work will assess the prevalence in the general population of the ineffectiveness of the anesthetic Lidocaine compared to males with ADHD and females with ADHD with or without PMS.
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. We will use an identical protocol at two sites: Jacobi hospital and Boston Clinical Trials. The controlled trial will assess the ability of lidocaine oral gel to block taste (e.g., sweet) in 100 teens and adults, half with a history of ADHD, and for females, we will compare the sub-groups with and without premenstrual syndrome (PMS). This study will also be compared with a similar assessment among a specialized ADHD population (NCT03563573), that does not respond to existing medication..
Interventions
DRUGLidocaine gel
Lidocaine gel (0.75 g premeasured dose of Septodont 5% oral gel NDC 0362-0221-10)
Sponsors
Jacobi Medical Center
Boston Clinical Trials
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.
Intervention model description
A group of 100 subjects will be assessed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Exclusion criteria
for both arms: (1) known adverse reactions to lidocaine; (2) ADHD, ADD, and other inattention disorders; (3) epilepsy, IQ \<80, severe head trauma, birth weight \<2270 grams, and severe autism; (4) treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers; (5) 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); (6) mouth sores; (7) Ehlers Danlos syndrome, (8) red hair, and (9) current pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Lidocaine Ineffectiveness | 30 minute visit, added on to a regular clinic visit | Subjects will be asked to identify each taste and its intensity on a 0 (no taste) to 10 (very intense) scale before and after application of Lidocaine. Lidocaine effectiveness was quantitated as the reduction or elimination of taste by lidocaine compared to taste scores reported before lidocaine. For each of the four before/after pairs, the change in taste intensity was calculated, a weighted average score was computed. Incorrectly identified tastes were excluded. Scores of a reduction in taste ≥50% were considered to be lidocaine effective. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Males Without ADHD ADHD-RS \<18 | 23 |
| Males With ADHD ADHD-RS ≥18 | 14 |
| Females Without ADHD and Without PMS ADHD-RS \<18 and Custom PMS \<12 | 22 |
| Females Without ADHD, But With PMS ADHD-RS \<18 and Custom PMS ≥12 | 5 |
| Females With ADHD and Without PMS ADHD-RS ≥18 and Custom PMS \<12 | 15 |
| Females With ADHD and With PMS ADHD-RS ≥18 and Custom PMS ≥12 | 11 |
| Total | 90 |
Baseline characteristics
| Characteristic | Males With ADHD | Females Without ADHD and Without PMS | Females Without ADHD, But With PMS | Females With ADHD and Without PMS | Females With ADHD and With PMS | Males Without ADHD | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 22 Participants | 5 Participants | 15 Participants | 11 Participants | 23 Participants | 90 Participants |
| Age, Continuous | 27 years STANDARD_DEVIATION 7.1 | 33 years STANDARD_DEVIATION 6.4 | 33 years STANDARD_DEVIATION 10 | 27 years STANDARD_DEVIATION 6.1 | 30 years STANDARD_DEVIATION 8.1 | 33 years STANDARD_DEVIATION 7.6 | 30 years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 2 Participants | 4 Participants | 4 Participants | 5 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 16 Participants | 3 Participants | 11 Participants | 7 Participants | 18 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 1 Participants | 2 Participants | 2 Participants | 8 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 4 Participants | 9 Participants | 6 Participants | 7 Participants | 44 Participants |
| Region of Enrollment United States | 14 Participants | 22 Participants | 5 Participants | 15 Participants | 11 Participants | 23 Participants | 90 Participants |
| Sex: Female, Male Female | 0 Participants | 22 Participants | 5 Participants | 15 Participants | 11 Participants | 0 Participants | 53 Participants |
| Sex: Female, Male Male | 14 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 23 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
Number of Subjects With Lidocaine Ineffectiveness
Subjects will be asked to identify each taste and its intensity on a 0 (no taste) to 10 (very intense) scale before and after application of Lidocaine. Lidocaine effectiveness was quantitated as the reduction or elimination of taste by lidocaine compared to taste scores reported before lidocaine. For each of the four before/after pairs, the change in taste intensity was calculated, a weighted average score was computed. Incorrectly identified tastes were excluded. Scores of a reduction in taste ≥50% were considered to be lidocaine effective.
Time frame: 30 minute visit, added on to a regular clinic visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Males Without ADHD | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine effective (gets numb) | 11 Participants |
| Males Without ADHD | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine ineffective (does not get numb) | 12 Participants |
| Males With ADHD | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine effective (gets numb) | 9 Participants |
| Males With ADHD | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine ineffective (does not get numb) | 5 Participants |
| Females Without ADHD and Without PMS | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine effective (gets numb) | 16 Participants |
| Females Without ADHD and Without PMS | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine ineffective (does not get numb) | 6 Participants |
| Females Without ADHD, But With PMS | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine effective (gets numb) | 5 Participants |
| Females Without ADHD, But With PMS | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine ineffective (does not get numb) | 0 Participants |
| Females With ADHD and Without PMS | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine effective (gets numb) | 15 Participants |
| Females With ADHD and Without PMS | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine ineffective (does not get numb) | 0 Participants |
| Females With ADHD and With PMS | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine effective (gets numb) | 3 Participants |
| Females With ADHD and With PMS | Number of Subjects With Lidocaine Ineffectiveness | Lidocaine ineffective (does not get numb) | 8 Participants |
Comparison: Women with PMS vs. without PMS.p-value: 0.017Fisher Exact
Comparison: Women with PMS and with ADHD vs. other womenp-value: 0.001Fisher Exact
Comparison: ADHD vs. no ADHDp-value: 0.8Fisher Exact