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New treatment option for Insomnia
Official title Enhancing Hypnotic Medication Discontinuation in Primary Care
ClinicalTrials.gov ID: NCT06435520
What this study is testing
- What it's testing
- Many individuals with insomnia seek treatment in primary care settings, where they often receive prescription hypnotic medications as their first and sometimes only treatment. However, extended use of these medications can lead to reliance and increased health risks, such as falls and cognitive impairments.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- a history of extended (\> 6 consecutive months) and frequent (\>5 nights/week on average) use of benzodiazepine (BZD) or non-BZD hypnotic medications;
- a desire to decrease/eliminate hypnotic use;
- a history of insomnia that meets DSM-560 criteria for insomnia disorder; and
- willingness to provide written informed consent to participate.
You likely can't join if
- a lifetime diagnosis of any psychotic disorder, suicide attempts, or bipolar disorder;
- presence of an unstable, untreated, or terminal major medical or psychiatric disorder;
- alcohol or drug abuse within the past year;
- current use of a BZD for another disorder in addition to insomnia (e.g., seizure disorder, restless leg syndrome, anxiety disorder);
- pregnancy;
- significant cognitive impairment as suggested by a score of ≤ 24 on the Folstein Mini-Mental State Examination (MMSE);
See the full eligibility criteria
- a history of extended (\> 6 consecutive months) and frequent (\>5 nights/week on average) use of benzodiazepine (BZD) or non-BZD hypnotic medications;
- a desire to decrease/eliminate hypnotic use;
- a history of insomnia that meets DSM-560 criteria for insomnia disorder; and
- willingness to provide written informed consent to participate.
- a lifetime diagnosis of any psychotic disorder, suicide attempts, or bipolar disorder;
- presence of an unstable, untreated, or terminal major medical or psychiatric disorder;
- alcohol or drug abuse within the past year;
- current use of a BZD for another disorder in addition to insomnia (e.g., seizure disorder, restless leg syndrome, anxiety disorder);
- pregnancy;
- significant cognitive impairment as suggested by a score of ≤ 24 on the Folstein Mini-Mental State Examination (MMSE);
- current use of medications known to cause insomnia (e.g., high dose corticosteroids);
- untreated comorbid sleep disorders;
- use of a sedating antidepressant or antipsychotic medication solely for sleep; and
- consuming \>2 alcoholic beverages/day ≥5 times/week or any use of marijuana ≥5 times/week.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, 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.