Hypnotic Dependence Among Those With InsomniaPhase 2NCT02831894
The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation
A Phase 2 study testing 0% Hypnotic Medication Taper, 25% Hypnotic Medication Taper and 10% Hypnotic Medication Taper in people with Hypnotic Dependence Among Those With Insomnia, run by National Jewish Health at 1 site in United States.
Trial summary
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 or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia… 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?
- 0% Hypnotic Medication Taper, 25% Hypnotic Medication Taper and 10% Hypnotic Medication Taper
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2015to 30 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 per 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 unstable, or "in-treatment" psychiatric disorder (e.g., major depression in psychotherapy or on 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 (e.g. chronic pain)
- current use of medications known to cause insomnia (e.g., corticosteroids)
Show all 9Show fewer
- a history or screening evidence of restless legs syndrome, circadian rhythm sleep disorder (e.g., delayed sleep phase syndrome), sleep apnea (AHI > 5), or periodic limb movement disorder (PLM index > 15)
- habitual bedtimes later than 2:00 AM or rising times later than 10:00 AM; (i) consuming > 2 alcoholic beverages per day at least 5 times per week
- pregnant women or mothers with care-taking responsibilities for infants due to the sleep-disruption caused by such circumstances.
Trial locations and contacts
1 site in 1 country.
About this study
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 or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia relief. However, more than 65 percent of individuals who are prescribed hypnotics use them for more than a year, and over 30 percent 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 as cognitive behavioral insomnia therapy or Cognitive Behavioral Therapy For Insomnia (CBTI) achieve sustained insomnia remission lon after a time limited course of treatment. However it is difficult for most long term hypnotic users to convert to a self management approach. Intervention that combine CBTI with a supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50 percent of patients who receive this treatment either fail to discontinue hypnotics or resume them over time. Previous research provides only rudimentary understanding of how to help long term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBTI techniques. This R34 gathered key pilot data to address these limitations. Specifically this project compared the currently recommended tapering pace which is a 25 percent dose reduction every two weeks with a slower 10 percent dose reduction every two weeks. The study also conducted all tapering in double blinded fashion. A total of 78 patients were enrolled and first completed a course of CBTI over a six week period. They they were randomized to of of the two tapering conditions or to a control (CTRL) condition in which their medication was not tapered. After the 20 week tapering period the study blind was eliminated and those in the CTRL condition were offered an open label tapering period. All patients were assessed for hypnotic use at the end of their respective tapering periods and then again 3 months later. Study key outcome measures included hypnotic discontinuation rates, nights per week hypnotics were used and weekly diazepam dose equivalents of hypnotics used. This line of research should inform clinical practice by helping to refine guidelines for tapering controlled substance hypnotic medications.
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 or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia relief. However, more than 65 percent of individuals who are prescribed hypnotics use them for more than a year, and over 30 percent 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 as cognitive behavioral insomnia therapy or CBTI achieve sustained insomnia remission lon after a time limited course of treatment. However it is difficult for most long term hypnotic users to convert to a self management approach. Intervention that combine CBTI with a supervised medication tapering or SMT have shown the greatest promise for achieving this outcome, but almost 50 percent of patients who receive this treatment either fail to discontinue hypnotics or resume them over time. Previous research provides only rudimentary understanding of how to help long term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBTI techniques. This R34 gathered key pilot data to address these limitations. Specifically this project compared the currently recommended tapering pace which is a 25 percent dose reduction every two weeks with a slower 10 percent dose reduction every two weeks. The study also conducted all tapering in double blinded fashion. A total of 78 patients were enrolled and first completed a course of CBTI over a six week period. They they were randomized to of of the two tapering conditions or to a control CTRL condition in which their medication was not tapered. After the 20 week tapering period the study blind was eliminated and those in the CTRL condition were offered an open label tapering period. All patients were assessed for hypnotic use at the end of their respective tapering periods and then again 3 months later. Study key outcome measures included hypnotic discontinuation rates, nights per week hypnotics were used and weekly diazepam dose equivalents of hypnotics used. This line of research should inform clinical practice by helping to refine guidelines for tapering controlled substance hypnotic medications.
- Being tested
- 0% Hypnotic Medication Taper, 25% Hypnotic Medication Taper, 10% Hypnotic Medication 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.
0% Hypnotic Medication TaperDrug
Also called No Drug Taper
Participants will not have their soporific hypnotic medication dosage changed during a 20 week blinded tapering period
25% Hypnotic Medication TaperDrug
Also called Quarter Drug Taper
Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 20 week blinded tapering period.
10% Hypnotic Medication TaperDrug
Also called Tenth Drug Taper
Participants will have their soporific hypnotic medication dosage reduced by 10% every two weeks during a 20 week blinded tapering period.
| Study group | Role | What they receive |
|---|---|---|
| 0% Hypnotic Medication Taper | Sham comparator | In this condition patients will be maintained on their baseline hypnotic medication dosage throughout a 20-week double-blinded tapering period. Receives: Drug: 0% Hypnotic Medication Taper |
| 25% Hypnotic Medication Taper | Active comparator | In this condition patients will have their current hypnotic medication dosage reduced by 25% every 2 weeks throughout a 20-week double-blinded tapering period. Receives: Drug: 25% Hypnotic Medication Taper |
| 10% Hypnotic Medication Taper | Active comparator | In this condition patients will have their current hypnotic medication dosage reduced by 10% every 2 weeks throughout a 20-week double-blinded tapering period. Receives: Drug: 10% Hypnotic Medication Taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Dropout Rate As Assessed By Analysis of Participant Register
Measurement will be taken by analysis of participant register of the proportion of participants in each tapering group who drop out before the end of the 20-week tapering period.
Measured: 20-week tapering phase
Hypnotic Discontinuation Rate As Assessed By Analysis of Study Pharmaceutical Records
Measurement will be taken by analysis of study pharmaceutical records of the proportion of participants in each tapering group who achieve full withdrawal of their hypnotic medication at or before the end of the tapering protocol.
Measured: 20-week tapering phase
Secondary outcomes (3)
Hypnotic Relapse Rate As Assessed by Analysis of Participant Reports
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 3-month follow-up visit.
Measured: Three-month follow-up phase
Time to Drop Out of the Tapering Protocol As Assessed by Analysis of Participant Register
Measurement will be taken by analysis of participant register and drop out dates of the time between the beginning of the 20-week and the effective date of participant drop out.
Measured: 20-week tapering phase
Absolute Change/Reduction in Diazepam Equivalents of Medication Being Used Nightly As Assessed by Study Pharmaceutical Records
Measurement will be taken by analysis of study pharmaceutical records of the absolute change or reduction in diazepam equivalents of medication being used nightly by study participants.
Measured: 20-week tapering phase and three-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 posted13 Jul 2016 (estimated)
- Study start2 Nov 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack D Edinger, Ph.D., Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831894
- Sponsor's protocol ID
- HS-2891
- Status last verified
- Oct 2019
- First submitted
- 13 May 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Publications
Edinger JD, Wamboldt FS, Johnson RL, Simmons B, Tsai S, Morin CM, Holm KE. Adherence to behavioral recommendations of cognitive behavioral therapy for insomnia predicts medication use after a structured medication taper. J Clin Sleep Med. 2023 Aug 1;19(8):1495-1503. doi: 10.5664/jcsm.10616.
PubMed 37086054
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation
- ClinicalTrials.gov ID
- NCT02831894
- Acronym / sponsor ID
- HS-2891
- Keywords
- insomnia, sedative hypnotics, hypnotic tapering
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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.
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 or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia relief. However, more than 65 percent of individuals who are prescribed hypnotics use them for more than a year, and over 30 percent 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 as cognitive behavioral insomnia therapy or Cognitive Behavioral Therapy For Insomnia (CBTI) achieve sustained insomnia remission lon after a time limited course of treatment. However it is difficult for most long term hypnotic users to convert to a self management approach. Intervention that combine CBTI with a supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50 percent of patients who receive this treatment either fail to discontinue hypnotics or resume them over time. Previous research provides only rudimentary understanding of how to help long term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBTI techniques. This R34 gathered key pilot data to address these limitations. Specifically this project compared the currently recommended tapering pace which is a 25 percent dose reduction every two weeks with a slower 10 percent dose reduction every two weeks. The study also conducted all tapering in double blinded fashion. A total of 78 patients were enrolled and first completed a course of CBTI over a six week period. They they were randomized to of of the two tapering conditions or to a control (CTRL) condition in which their medication was not tapered. After the 20 week tapering period the study blind was eliminated and those in the CTRL condition were offered an open label tapering period. All patients were assessed for hypnotic use at the end of their respective tapering periods and then again 3 months later. Study key outcome measures included hypnotic discontinuation rates, nights per week hypnotics were used and weekly diazepam dose equivalents of hypnotics used. This line of research should inform clinical practice by helping to refine guidelines for tapering controlled substance hypnotic medications.
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 or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia relief. However, more than 65 percent of individuals who are prescribed hypnotics use them for more than a year, and over 30 percent 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 as cognitive behavioral insomnia therapy or CBTI achieve sustained insomnia remission lon after a time limited course of treatment. However it is difficult for most long term hypnotic users to convert to a self management approach. Intervention that combine CBTI with a supervised medication tapering or SMT have shown the greatest promise for achieving this outcome, but almost 50 percent of patients who receive this treatment either fail to discontinue hypnotics or resume them over time. Previous research provides only rudimentary understanding of how to help long term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBTI techniques. This R34 gathered key pilot data to address these limitations. Specifically this project compared the currently recommended tapering pace which is a 25 percent dose reduction every two weeks with a slower 10 percent dose reduction every two weeks. The study also conducted all tapering in double blinded fashion. A total of 78 patients were enrolled and first completed a course of CBTI over a six week period. They they were randomized to of of the two tapering conditions or to a control CTRL condition in which their medication was not tapered. After the 20 week tapering period the study blind was eliminated and those in the CTRL condition were offered an open label tapering period. All patients were assessed for hypnotic use at the end of their respective tapering periods and then again 3 months later. Study key outcome measures included hypnotic discontinuation rates, nights per week hypnotics were used and weekly diazepam dose equivalents of hypnotics used. This line of research should inform clinical practice by helping to refine guidelines for tapering controlled substance hypnotic medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0% Hypnotic Medication Taper | Sham comparator | Drug: 0% Hypnotic Medication TaperIn this condition patients will be maintained on their baseline hypnotic medication dosage throughout a 20-week double-blinded tapering period. |
| 25% Hypnotic Medication Taper | Active comparator | Drug: 25% Hypnotic Medication TaperIn this condition patients will have their current hypnotic medication dosage reduced by 25% every 2 weeks throughout a 20-week double-blinded tapering period. |
| 10% Hypnotic Medication Taper | Active comparator | Drug: 10% Hypnotic Medication TaperIn this condition patients will have their current hypnotic medication dosage reduced by 10% every 2 weeks throughout a 20-week double-blinded tapering period. |
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 per 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 (9 listed)
- an untreated unstable, or "in-treatment" psychiatric disorder (e.g., major depression in psychotherapy or on 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 (e.g. chronic pain)
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 |
|---|---|---|
| 0% Hypnotic Medication TaperAlso: No Drug TaperParticipants will not have their soporific hypnotic medication dosage changed during a 20 week blinded tapering period | Drug | 0% Hypnotic Medication Taper |
| 25% Hypnotic Medication TaperAlso: Quarter Drug TaperParticipants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 20 week blinded tapering period. | Drug | 25% Hypnotic Medication Taper |
| 10% Hypnotic Medication TaperAlso: Tenth Drug TaperParticipants will have their soporific hypnotic medication dosage reduced by 10% every two weeks during a 20 week blinded tapering period. | Drug | 10% Hypnotic Medication Taper |
Primary outcome
Participant Dropout Rate As Assessed By Analysis of Participant Register
Time frame: 20-week tapering phase
Measurement will be taken by analysis of participant register of the proportion of participants in each tapering group who drop out before the end of the 20-week tapering period.
Hypnotic Discontinuation Rate As Assessed By Analysis of Study Pharmaceutical Records
Time frame: 20-week tapering phase
Measurement will be taken by analysis of study pharmaceutical records of the proportion of participants in each tapering group who achieve full withdrawal of their hypnotic medication at or before the end of the tapering protocol.
3 secondary outcomes
Hypnotic Relapse Rate As Assessed by Analysis of Participant Reports
Time frame: Three-month follow-up phase
Time to Drop Out of the Tapering Protocol As Assessed by Analysis of Participant Register
Time frame: 20-week tapering phase
Absolute Change/Reduction in Diazepam Equivalents of Medication Being Used Nightly As Assessed by Study Pharmaceutical Records
Time frame: 20-week tapering phase and three-month follow-up phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Derived from this study: PubMed 37086054Edinger JD, Wamboldt FS, Johnson RL, Simmons B, Tsai S, Morin CM, Holm KE. Adherence to behavioral recommendations of cognitive behavioral therapy for insomnia predicts medication use after a structured medication taper. J Clin Sleep Med. 2023 Aug 1;19(8):1495-1503. doi: 10.5664/jcsm.10616.
- 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.
Related trials for Hypnotic Dependence Among Those With Insomnia
Active, not recruitingPhase 3
Use of Blinded Tapering for Hypnotic Discontinuation
Hypnotic Dependence Among Those With Insomnia
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0% Hypnotic Medication Taper, 25% Hypnotic Medication Taper and 10% Hypnotic Medication 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 9 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: finished, as of the sponsor's last update on 30 Oct 2019. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant Dropout Rate As Assessed By Analysis of Participant Register (time frame: 20-week tapering phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02831894, which also lists 1 linked publication.
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 30 Oct 2019.