BridgeMD
New treatment option for Insomnia
Official title A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia
ClinicalTrials.gov ID: NCT07542756
What this study is testing
What is Diphenhydramine, 25 mg?
Diphenhydramine, 25 mg is an investigational medicine, being studied as a potential treatment for insomnia.
Also referred to as Benadryl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk/benefit profile (doxepin).
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Adults aged 18-80 years.
- Meet DSM-5 criteria for Insomnia Disorder.
- Score ≥15 on the Insomnia Severity Index (ISI).
- Sleep initiation and/or maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights/week, with a duration of ≥3 months.
- Willingness to discontinue use of all sleep-related medications prior to enrollment.
You likely can't join if
- Patients will be ineligible if they meet any of the following criteria: self-reported daytime napping (≥1 hour per day on ≥3 days per week); a...
- Age \ 80 years old
- Inadequate English language comprehension
- Minimal facility with smartphones, computers, i-Pads, or the internet. Women's Health Given the potential for teratogenic effects with at least...
- Acute or unstable psychiatric conditions
- Unstable medical condition, significant medical disorder, or acute illness (as determined by their PCP), within one month prior to the study period.
See the full eligibility criteria
- Adults aged 18-80 years.
- Meet DSM-5 criteria for Insomnia Disorder.
- Score ≥15 on the Insomnia Severity Index (ISI).
- Sleep initiation and/or maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights/week, with a duration of ≥3 months.
- Willingness to discontinue use of all sleep-related medications prior to enrollment.
- Completion of a 2-week washout period before starting any study medication.
- Willingness to provide clinician assent for participation.
- Patients will be ineligible if they meet any of the following criteria: self-reported daytime napping (≥1 hour per day on ≥3 days per week); a history of suicidal attempts or current ideation, acute or chronic...
- Age \ 80 years old
- Inadequate English language comprehension
- Minimal facility with smartphones, computers, i-Pads, or the internet. Women's Health Given the potential for teratogenic effects with at least trazodone (FDA Class C), women intending to become pregnant, or who are...
- Acute or unstable psychiatric conditions
- Unstable medical condition, significant medical disorder, or acute illness (as determined by their PCP), within one month prior to the study period.
- Significant liver or kidney problems
- Pheochromocytoma or porphyria (contraindicated for trazodone)
- Epilepsy or Seizure Disorder (contraindicated for trazodone)
- Glaucoma or urinary retention (contraindicated for doxepin)
- Increased ocular pressure (contraindicated for diphenhydramine)
- Diagnosis of alcohol or substance use disorder within 2 years prior to the screening visit
- Inability to refrain from drinking alcohol or substance use for at least 3 consecutive days Sleep Disorders and Sleep Habits
- Any lifetime history of (diagnosis of) breathing disorders, including COPD and sleep apnea.
- Shift work related sleep disorder (work \~11pm to 7am and "day sleeper") and rotating shiftwork schedules
- Circadian rhythm disorders (phase advance or phase delay syndromes)
- Self-reported usual daytime napping ≥1 hour per day (3 or more days per week) Medications and Concomitant meds
- Known hypersensitivity or contraindication to study drugs
- Known hypersensitivity or contraindication to drugs of the same class as the study treatments
- Known hypersensitivity or contraindication to any excipients of the study drug formulation
- Treatment with CNS active drugs prohibited by the protocol for five half-lives of the respective drug (or 2 weeks) Lifestyle
- Heavy tobacco use (≥1 pack of cigarettes a day or inability to refrain from smoking during the night)
- Not able or willing to stop treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.