Hypnotic Dependence Among Those With InsomniaPhase 3NCT04050176
Use of Blinded Tapering for Hypnotic Discontinuation
A Phase 3 study testing Hypnotic Medication Open-Label Taper and Hypnotic Medication Blinded Taper in people with Hypnotic Dependence Among Those With Insomnia, run by National Jewish Health at 1 site in United States.
Trial summary
The study will employ a randomized longitudinal clinical trial design to evaluate the relative efficacy of a blinded hypnotic tapering protocol when used in combination with therapist delivered Cognitive Behavioral Therapy for Insomnia (CBTI) for enhancing hypnotic discontinuation rates. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypnotic Dependence Among Those With Insomnia
- What is being tested?
- Hypnotic Medication Open-Label Taper and Hypnotic Medication Blinded Taper
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be 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;
- express interest in discontinuing hypnotic use and learning to manage their insomnia without medications;
- report one or more failed attempts to discontinue hypnotic use in the past;
- provide written consent to participate.
- have an insomnia severity index score > 10 indicating at least mild insomnia symptoms without sleep medication
Who cannot join
- an untreated, or unstable psychiatric disorder as suggested by current active symptoms or a medication regimen that has been changed within the past 2 months;
- a lifetime diagnosis of any psychotic or bipolar disorder
- an imminent risk for suicide
- evidence of alcohol or drug abuse (other than hypnotics) within the past year, since such abuse patterns suggest specialized substance abuse treatment may be indicated
- unstable or terminal physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia) or sleep disruptive medical condition
- current use of medications known to cause insomnia (e.g., corticosteroids)
Show all 11Show fewer
- screening evidence of circadian rhythm sleep disorder (e.g., delayed sleep phase syndrome) or other sleep disorder (e.g. narcolepsy, idiopathic hypersomnolence, Rapid Eye Movement (REM) behavior disorder) for which CBTI would not represent optimal therapy
- habitual bedtimes later than 2:00 AM or rising times later than 10:00 AM;
- consuming > 2 alcoholic beverages/day or any cannabis products at least 5 times/week
- pregnant women or mothers with care-taking responsibilities for infants due to the sleep-disruption caused by such circumstances
- clinical or polysomnographic evidence of undiagnosed and untreated restless legs syndrome (RLS), sleep apnea or periodic limb movements (PLMS) that require alternative therapies and would limit participants' responses to CBTI
Trial locations and contacts
1 site in 1 country.
About this study
The study will employ a randomized longitudinal clinical trial design to evaluate the relative efficacy of a blinded hypnotic tapering protocol when used in combination with therapist delivered Cognitive Behavioral Therapy for Insomnia (CBTI) for enhancing hypnotic discontinuation rates. A blinded SMT+CBTI intervention will be compared to open-label SMT+CBTI.
Read the detailed description
Treatment-seeking insomnia sufferers most often present in primary care venues where the first and usually only treatment is a prescription for a sedative hypnotic, typically a benzodiazepine (BZD) or newer benzodiazepine receptor agonist (BzRA). For some patients, short-term or intermittent hypnotic use provides satisfactory insomnia relief. However, more than 65% of individuals who are prescribed hypnotics use them for more than a year, and > 30% remain on these agents for more than five years. Whereas some patients may appreciate partial or full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of these agents may not represent optimal therapy. Many insomnia patients who participate in non-drug insomnia therapy such as cognitive behavioral insomnia therapy (CBT-I) achieve sustained insomnia remission long after a time-limited course of treatment. However, it is difficult for most long-term hypnotic users to convert from use of medications to a self-management approach. Interventions that combine CBT-I with supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50% of patients who receive this assistance either fail to discontinue their hypnotics or return to them even if they do achieve short-term abstinence. Our clinical and research observations suggest that psychological factors including sleep-related performance anxiety, low sleep-related self-efficacy and beliefs about needs for medications interact to lead to difficulties abstaining from hypnotic use. Moreover, our highly promising pilot data suggest that such factors may be mitigated by use of a blinded SMT protocol which appears to increase rates of medication abstinence. The current project will use a 2 x 4 randomized longitudinal clinical trial design to test the relative efficacy of our highly promising blinded tapering protocol, vis a vis open-label tapering, when combined with therapist delivered CBT-I. A sample of 260 will be enrolled, complete pre-intervention baseline measures and then be randomly assigned to: (1) a blinded hypnotic SMT + therapist delivered CBT-I; or (2) open-label tapering + CBT-I. During treatment all enrollees will first 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. They then will begin a 10 week SMT during which they are provided a blinded or open-label tapering SMT protocol. During this phase they will have their hypnotic medication doses reduced by 25% every two weeks. Immediately after completing the SMT and again at 3- and 6-month follow-ups they will complete study outcome measures. The primary study outcome will be hypnotic discontinuance rates of the two treatment groups. Secondary outcomes include nights of hypnotic use per week, nightly average dosage of hypnotic used in diazepam equivalents as well as scores on sleep quality, daytime fatigue and quality of life. This study will lead to refining guidelines for tapering methods and providing a better understanding of treatment outcome predictors so as to provide more successful, person-centered interventions.
- Being tested
- Hypnotic Medication Open-Label Taper, Hypnotic Medication Blinded Taper
- Keywords
- insomnia, sedative hypnotics, hypnotic tapering
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic Medication Open-Label TaperBehavioural
Also called Quarter Drug Open-Label Taper
Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 10 week open-label tapering period.
Hypnotic Medication Blinded TaperBehavioural
Also called Quarter Drug Blinded-Label Taper
Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 10 week blinded tapering period.
| Study group | Role | What they receive |
|---|---|---|
| Blinded Hypnotic Medication Taper (BT) | Experimental | Participants assigned to the Blinded Taper group will not know the medication dose they receive during the Structured Medication Taper (SMT) phase. Receives: Behavioral: Hypnotic Medication Blinded Taper |
| Open-Label Hypnotic Medication Taper (OLT) | Active comparator | Participants assigned to the Open-Label Hypnotic Medication Taper group will know the medication dose they receive during the SMT phase. Receives: Behavioral: Hypnotic Medication Open-Label Taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypnotic Discontinuation Rate As Assessed By Analysis of Study Pharmaceutical Records
the proportion of participants in each treatment group who achieve full withdrawal of their BZD/BzRA medication without switching to any alternative prescription medication, used on- (e.g., suvorexant) or off-label (e.g. trazodone) to promote sleep
Measured: 10-week tapering phase
Secondary outcomes (3)
Nights of Hypnotic use/week
Measurement will be taken by analysis of participant reports of the proportion of participants in each tapering group who achieve medication abstinence but subsequently return to hypnotic use by the 6-month follow-up visit
Measured: Six-month follow up phase
Weekly average dosage of hypnotic used in diazepam equivalents
Measurement will be taken by analysis of participant reports of their average weekly medication use within proportion of participants in each tapering group who achieve medication abstinence but subsequently return to hypnotic use by the 6-month follow-up visit.
Measured: Six-month follow up phase
Use of over the counter sleep aids (e.g. Benadryl) as well as use of substances (alcohol, marijuana)
Measurement will be taken by analysis of participant reports of their average weekly medication use within proportion of participants in each tapering group who achieve medication abstinence but subsequently return the use of over the counter sleep aids (e.g. Benadryl) as well as use of substances (alcohol, marijuana) by the 6-month follow-up phase
Measured: Six-month follow up phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start16 Dec 2019
- Primary completion31 Dec 2024
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypnotic Dependence Among Those With InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: Blinded and Unblinded.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jack D Edinger, Ph.D., Principal investigator, National Jewish HealthFredrick Wamboldt, M.D., Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050176
- Sponsor's protocol ID
- HS3239
- Status last verified
- Feb 2025
- First submitted
- 7 Aug 2019
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Archives. All data related to the clinical trial will be placed in the public domain in a time frame consistent with NIMH policies. Primary datasets will be made available via CDROM. These datasets will not include any personal identification related to participants or clinical sites beyond the usual numerical keys. Variable dictionaries, detailing variable description, format, value domain and labels, will be produced. Raw data will be exported in comma-separated format, to be readable by all major statistical software. Archives will also include data collection instructions and scoring algorithms for inventories. All reading material will be archived in PDF format.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Blinded Tapering for Hypnotic Discontinuation
- ClinicalTrials.gov ID
- NCT04050176
- Acronym / sponsor ID
- HS3239
- Keywords
- insomnia, sedative hypnotics, hypnotic tapering
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will employ a randomized longitudinal clinical trial design to evaluate the relative efficacy of a blinded hypnotic tapering protocol when used in combination with therapist delivered Cognitive Behavioral Therapy for Insomnia (CBTI) for enhancing hypnotic discontinuation rates. A blinded SMT+CBTI intervention will be compared to open-label SMT+CBTI.
Detailed description
Treatment-seeking insomnia sufferers most often present in primary care venues where the first and usually only treatment is a prescription for a sedative hypnotic, typically a benzodiazepine (BZD) or newer benzodiazepine receptor agonist (BzRA). For some patients, short-term or intermittent hypnotic use provides satisfactory insomnia relief. However, more than 65% of individuals who are prescribed hypnotics use them for more than a year, and > 30% remain on these agents for more than five years. Whereas some patients may appreciate partial or full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of these agents may not represent optimal therapy. Many insomnia patients who participate in non-drug insomnia therapy such as cognitive behavioral insomnia therapy (CBT-I) achieve sustained insomnia remission long after a time-limited course of treatment. However, it is difficult for most long-term hypnotic users to convert from use of medications to a self-management approach. Interventions that combine CBT-I with supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50% of patients who receive this assistance either fail to discontinue their hypnotics or return to them even if they do achieve short-term abstinence. Our clinical and research observations suggest that psychological factors including sleep-related performance anxiety, low sleep-related self-efficacy and beliefs about needs for medications interact to lead to difficulties abstaining from hypnotic use. Moreover, our highly promising pilot data suggest that such factors may be mitigated by use of a blinded SMT protocol which appears to increase rates of medication abstinence. The current project will use a 2 x 4 randomized longitudinal clinical trial design to test the relative efficacy of our highly promising blinded tapering protocol, vis a vis open-label tapering, when combined with therapist delivered CBT-I. A sample of 260 will be enrolled, complete pre-intervention baseline measures and then be randomly assigned to: (1) a blinded hypnotic SMT + therapist delivered CBT-I; or (2) open-label tapering + CBT-I. During treatment all enrollees will first 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. They then will begin a 10 week SMT during which they are provided a blinded or open-label tapering SMT protocol. During this phase they will have their hypnotic medication doses reduced by 25% every two weeks. Immediately after completing the SMT and again at 3- and 6-month follow-ups they will complete study outcome measures. The primary study outcome will be hypnotic discontinuance rates of the two treatment groups. Secondary outcomes include nights of hypnotic use per week, nightly average dosage of hypnotic used in diazepam equivalents as well as scores on sleep quality, daytime fatigue and quality of life. This study will lead to refining guidelines for tapering methods and providing a better understanding of treatment outcome predictors so as to provide more successful, person-centered interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: Blinded and Unblinded.
| Arm | Type | Receives |
|---|---|---|
| Blinded Hypnotic Medication Taper (BT) | Experimental | Behavioral: Hypnotic Medication Blinded TaperParticipants assigned to the Blinded Taper group will not know the medication dose they receive during the Structured Medication Taper (SMT) phase. |
| Open-Label Hypnotic Medication Taper (OLT) | Active comparator | Behavioral: Hypnotic Medication Open-Label TaperParticipants assigned to the Open-Label Hypnotic Medication Taper group will know the medication dose they receive during the SMT phase. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be 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;
- express interest in discontinuing hypnotic use and learning to manage their insomnia without medications;
- report one or more failed attempts to discontinue hypnotic use in the past;
- provide written consent to participate.
Key exclusion criteria (11 listed)
- an untreated, or unstable psychiatric disorder as suggested by current active symptoms or a medication regimen that has been changed within the past 2 months;
- a lifetime diagnosis of any psychotic or bipolar disorder
- an imminent risk for suicide
- evidence of alcohol or drug abuse (other than hypnotics) within the past year, since such abuse patterns suggest specialized substance abuse treatment may be indicated
- unstable or terminal physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia) or sleep disruptive medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotic Medication Open-Label TaperAlso: Quarter Drug Open-Label TaperParticipants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 10 week open-label tapering period. | Behavioural | Open-Label Hypnotic Medication Taper (OLT) |
| Hypnotic Medication Blinded TaperAlso: Quarter Drug Blinded-Label TaperParticipants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 10 week blinded tapering period. | Behavioural | Blinded Hypnotic Medication Taper (BT) |
Primary outcome
Hypnotic Discontinuation Rate As Assessed By Analysis of Study Pharmaceutical Records
Time frame: 10-week tapering phase
the proportion of participants in each treatment group who achieve full withdrawal of their BZD/BzRA medication without switching to any alternative prescription medication, used on- (e.g., suvorexant) or off-label (e.g. trazodone) to promote sleep
3 secondary outcomes
Nights of Hypnotic use/week
Time frame: Six-month follow up phase
Weekly average dosage of hypnotic used in diazepam equivalents
Time frame: Six-month follow up phase
Use of over the counter sleep aids (e.g. Benadryl) as well as use of substances (alcohol, marijuana)
Time frame: Six-month follow up phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Yes. Data Archives. All data related to the clinical trial will be placed in the public domain in a time frame consistent with NIMH policies. Primary datasets will be made available via CDROM. These datasets will not include any personal identification related to participants or clinical sites beyond the usual numerical keys. Variable dictionaries, detailing variable description, format, value domain and labels, will be produced. Raw data will be exported in comma-separated format, to be readable by all major statistical software. Archives will also include data collection instructions and scoring algorithms for inventories. All reading material will be archived in PDF format.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack D Edinger, Ph.D. principal investigator
National Jewish Health
Fredrick Wamboldt, M.D. principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypnotic Medication Open-Label Taper and Hypnotic Medication Blinded Taper in people with Hypnotic Dependence Among Those With Insomnia, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypnotic Discontinuation Rate As Assessed By Analysis of Study Pharmaceutical Records (time frame: 10-week tapering phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.