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Tapering Strategies for Sleeping Pill Dependence

Phase 2
Waitlist Available
Led By Fredrick Wamboldt, M.D.
Research Sponsored by National Jewish Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently using one or more BZD or newer BzRA hypnotics at bedtime for insomnia management
Have been using one or more such agents at least 5 nights/week for at least the past 12 months
Must not have
Untreated or unstable psychiatric disorder as suggested by current active symptoms or a medication regimen that has been changed within the past 2 months
Lifetime diagnosis of any psychotic or bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six-month follow up phase
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two treatments to help people stop taking sleeping pills, one using hypnosis and one not.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects aren't specified here but generally could include withdrawal symptoms such as anxiety, insomnia rebound, mood changes, and physical discomfort. CBTI itself has no known side effects but changing medication routines should be monitored by professionals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently taking medication for insomnia at bedtime.
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I have been using medication for my condition almost every night for the past year.
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I have mild insomnia symptoms without using sleep medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My mental health is stable, and my medications haven't changed recently.
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I have been diagnosed with a psychotic or bipolar disorder in my lifetime.
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I do not have any terminal illnesses, severe neurological diseases, or conditions that severely disrupt my sleep.
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I am currently taking medication that can cause sleeplessness.
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I have sleep issues like restless legs or sleep apnea not treated yet.
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I have a sleep disorder that cannot be best treated with cognitive behavioral therapy for insomnia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six-month follow up phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and six-month follow up phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hypnotic Discontinuation Rate As Assessed By Analysis of Study Pharmaceutical Records
Secondary study objectives
Nights of Hypnotic use/week
Use of over the counter sleep aids (e.g. Benadryl) as well as use of substances (alcohol, marijuana)
Weekly average dosage of hypnotic used in diazepam equivalents

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Blinded Hypnotic Medication Taper (BT)Experimental Treatment1 Intervention
Participants assigned to the Blinded Taper group will not know the medication dose they receive during the Structured Medication Taper (SMT) phase.
Group II: Open-Label Hypnotic Medication Taper (OLT)Active Control1 Intervention
Participants assigned to the Open-Label Hypnotic Medication Taper group will know the medication dose they receive during the SMT phase.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,579 Previous Clinical Trials
3,316,665 Total Patients Enrolled
National Jewish HealthLead Sponsor
143 Previous Clinical Trials
316,940 Total Patients Enrolled
Fredrick Wamboldt, M.D.Principal InvestigatorNational Jewish Health
~24 spots leftby Jun 2025
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