Tapering Strategies for Sleeping Pill Dependence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores methods to help individuals stop relying on sleeping pills. It compares two dose-reduction strategies: one where participants know their dose and another where they do not. Both groups receive therapy to manage insomnia without medication. This trial suits individuals who have used sleeping pills most nights over the past year, wish to stop, and have previously attempted to quit without success. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
Yes, participants will need to stop taking their current sleeping pills as the trial is focused on helping them discontinue hypnotic use.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that many individuals who rely on sleeping pills can safely reduce their use by gradually decreasing the dosage. This reduction can occur without hospitalization.
However, long-term use of sleeping pills carries risks, including an increased chance of serious health issues. Therefore, it is important to seek a doctor's guidance when reducing these medications. Most people manage the process well, though experiences can vary.
In summary, while sleeping pills pose some risks, many can safely reduce their use with professional guidance.12345Why are researchers excited about this trial?
Researchers are excited about these tapering strategies for sleeping pill dependence because they offer innovative approaches to reducing medication use. Unlike simply cutting back on doses, the Open-Label Hypnotic Medication Taper (OLT) allows participants to know their medication dose, potentially empowering them and reducing anxiety about tapering. On the other hand, the Blinded Hypnotic Medication Taper (BT) keeps participants unaware of their dose changes, which may help minimize psychological dependence on the medication. These strategies aim to provide more effective, personalized ways to manage sleeping pill dependence, which is a significant step beyond current standard practices.
What evidence suggests that this trial's treatments could be effective for sleeping pill dependence?
Studies have shown that gradually reducing the use of sleeping pills, combined with Cognitive Behavioral Therapy for Insomnia (CBTI), can help people stop using these medications. Specifically, research found that supervised reduction led to a 90% decrease in the amount of benzodiazepines used and an 80% decrease in their frequency. Successfully stopping sleeping pills was linked to better sleep, less anxiety, and improved overall health. In this trial, participants will be assigned to different tapering strategies. One method, "blinded tapering," might make it easier to quit sleeping pills, as participants will not know the medication dose they receive. Another group will follow an open-label tapering strategy, where participants will know their medication dose. These findings suggest that a structured plan to slowly reduce sleeping pill use could be a good option for those wanting to cut back or stop altogether.678910
Who Is on the Research Team?
Jack D Edinger, PhD
Principal Investigator
National Jewish Health
Fredrick Wamboldt, M.D.
Principal Investigator
National Jewish Health
Are You a Good Fit for This Trial?
This trial is for adults who've been using certain sleep medications nightly for over a year, want to stop but have failed before. They must have mild insomnia without meds and can't join if they have unstable mental health issues, substance abuse (except hypnotics), severe illnesses like cancer or dementia, other untreated sleep disorders, or use meds that disrupt sleep.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete pre-intervention baseline measures
Treatment
Participants receive one-on-one treatment sessions with a trained CBT-I therapist over a 6-week period while maintaining baseline doses of their respective hypnotics
Structured Medication Taper (SMT)
Participants undergo a 10-week SMT with either a blinded or open-label tapering protocol, reducing hypnotic medication doses by 25% every two weeks
Follow-up
Participants are monitored for hypnotic discontinuation rates and secondary outcomes such as sleep quality and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Hypnotic Medication
Trial Overview
The study tests two ways of stopping sleep meds while getting Cognitive Behavioral Therapy for Insomnia (CBTI). One group knows when their medication dose is reduced (open-label taper), the other doesn't (blinded taper). The goal is to see which method helps more people successfully quit these meds.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants assigned to the Blinded Taper group will not know the medication dose they receive during the Structured Medication Taper (SMT) phase.
Participants assigned to the Open-Label Hypnotic Medication Taper group will know the medication dose they receive during the SMT phase.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Jewish Health
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Management of Hypnotic Discontinuation in Chronic ...
A regimen that has been frequently used in hypnotic reduction studies is to decrease initial dosage by 25% slices weekly or every other week until the smallest ...
Randomized Clinical Trial of Supervised Tapering and ...
RESULTS: All three interventions produced significant reductions in both the quantity (90% reduction) and frequency (80% reduction) of benzodiazepine use, and ...
3.
researchgate.net
researchgate.net/publication/5475791_Hypnotic_Discontinuation_in_Chronic_Insomnia_Impact_of_Psychological_Distress_Readiness_to_Change_and_Self-Efficacy(PDF) Hypnotic Discontinuation in Chronic Insomnia
Successful hypnotic discontinuation was associated with overall improvement of insomnia, anxiety and distress symptoms, perceived health and ...
A narrative review of strategies for discontinuing long-term ...
Clinical practice and evidence-based reviews agree that BZ dependence is difficult to treat: without support, only 7% of misusers manage to stop taking them.
Hypnotic Discontinuation Using a Blinded (Masked) ...
Blinded tapering is a promising new method for improving hypnotic discontinuation among patients treated with a combination of hypnotic tapering plus CBTI.
Risks of Chronic Hypnotic Use - NCBI - NIH
There is an epidemiologic consensus that hypnotic use is associated with increased risk of death. Chronic hypnotic use is also strongly associated with ...
Alliance for Sleep Clinical Practice Guideline on Switching ...
No data were found to determine whether switching to a longer half-life hypnotic drug decreases withdrawal or rebound insomnia symptoms. Currently, there is ...
Study Details | NCT02831894 | The Role of Tapering Pace ...
Study key outcome measures included hypnotic discontinuation rates, nights per week hypnotics were used and weekly diazepam dose equivalents of hypnotics used.
Sedative, Hypnotic, Anxiolytic Use Disorders Treatment & ...
Many patients who have mild dependence on benzodiazepines can be managed by a slow taper of the drug in an outpatient setting. However, this is ...
an examination of middle-aged and older adults with insomnia ...
Increasing severity of hypnotic dependence was associated with a higher likelihood of wishing to decrease sleep medications (odds ratio = 1.73, 95% confidence ...
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