volunteers will receive once daily cobicistat for 5 days. On day 5, participants will receive a single oral dose of GHB. After a washout period for 7 days, volunteers will receive once-daily placebo for 5 days. On day 5, participants will receive a single oral dose of GHB

volunteers will receive once-daily placebo for 5 days. On day 5, participants will receive a single oral dose of GHB. After a washout period for 7 days, volunteers will receive once daily cobicistat for 5 days. On day 5, participants will receive a single oral dose of GHB.

Pharmacokinetic Interactions

once daily cobicistat (150 mg QD) for 5 days

Cobicistat 150 MG

once daily lactose capsules (as aspect cobicistat capsules)

Placebo

single oral dose of GHB (25 mg/kg) on days 5 and 17

José

Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat

% of participants developing related adverse events.

Addiction Research Center Inventory (ARCI) 49 item short for questionnaire (measures sedation, euphoria, dysphoria, energy and stimulation)

visual analog scales (VAS) 15 items (about sensations (good or bad), feelings, nausea and vomit) determined by horizontal line of 100 mm. The ends are defined as the limits of the parameter to be measured orientated from the left (minimum intensity) to the right (maximum intensity).

Fundacio Lluita Contra la SIDA

Participants will undergo two 5-day treatment periods (COBI and placebo) separated by a 7-day washout period:
COBI period: volunteers will receive once daily cobicistat (150 mg QD) for 5 days.
Placebo period: volunteers will receive once-daily placebo (lactose) for 5 days. On day 5 of each treatment period, participants will receive a single oral dose of GHB (25 mg/kg).

Subjects will then receive auricular acupuncture (NADA Protocol) twice weekly for eight consecutive weeks. Subjects will be evaluated for seizure frequency changes by self-reported diary; adverse events; study feasibility; and mental and physiological symptoms at baseline, 12 weeks (completion of acupuncture), and 16 weeks (1 month after treatment follow up, end of study). A single sham procedure will be tested following treatment completion for use in future studies.

The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.

Auricular Acupuncture

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Of subjects who receive the first Auricular Acupuncture treatment, we will measure the percentage that goes on to complete the entire 8 week active treatment period.

Completion Rate of Auricular Acupuncture in Patients With NES

We will report the types and rates of any adverse events collected from subject diaries.

Adverse Events

For each subject enrolled, we will measure the percentage of diary entries each patient completed over the four month study period.

Compliance Rates of NES Seizure Diary

Of subjects completing the 8 week active treatment period, we will compare each subject's 1 month baseline frequency with frequency immediately upon completion of the active treatment period, and at 1 month follow up (3 months after baseline)

Trend for Auricular Acupuncture to Reduce NES Frequency

Overall Study

Edward Maa

Convulsion, Non-Epileptic

Auricular acupuncture

Denver Health Medical Center

Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures

There is no plan to make individual participant data (IPD) available to other researchers.

erectile dysfunction/癲癇性発作

Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat

Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures

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