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The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation

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ClinicalTrials.gov Identifier: NCT02831894
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
National Jewish Health

Brief 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 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.

Condition or disease Intervention/treatment Phase
Hypnotic Dependence Among Those With Insomnia Drug: 0% Hypnotic Medication Taper Drug: 25% Hypnotic Medication Taper Drug: 10% Hypnotic Medication Taper Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation
Actual Study Start Date : November 2, 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2019

Arm Intervention/treatment
Sham Comparator: 0% Hypnotic Medication Taper
In this condition patients will be maintained on their baseline hypnotic medication dosage throughout a 20-week double-blinded tapering period.
Drug: 0% Hypnotic Medication Taper
Participants will not have their soporific hypnotic medication dosage changed during a 20 week blinded tapering period
Other Name: No Drug Taper

Active Comparator: 25% Hypnotic Medication Taper
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.
Drug: 25% Hypnotic Medication Taper
Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 20 week blinded tapering period.
Other Name: Quarter Drug Taper

Active Comparator: 10% Hypnotic Medication Taper
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.
Drug: 10% Hypnotic Medication Taper
Participants will have their soporific hypnotic medication dosage reduced by 10% every two weeks during a 20 week blinded tapering period.
Other Name: Tenth Drug Taper




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Hypnotic Relapse Rate As Assessed by Analysis of Participant Reports [ Time Frame: Three-month follow-up phase ]
    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.

  2. Time to Drop Out of the Tapering Protocol As Assessed by Analysis of Participant Register [ Time Frame: 20-week tapering phase ]
    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.

  3. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. be currently using one or more BZD or newer BzRA hypnotics at bedtime for insomnia management;
  2. have been using one or more such agents at least 5 nights per week for at least the past 12 months;
  3. express interest in discontinuing hypnotic use and learning to manage their insomnia without medications;
  4. report one or more failed attempts to discontinue hypnotic use in the past;
  5. provide written consent to participate.
  6. have an insomnia severity index score > 10 indicating at least mild insomnia symptoms without sleep medication

Exclusion Criteria:

  1. 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)
  2. a lifetime diagnosis of any psychotic or bipolar disorder
  3. an imminent risk for suicide
  4. 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
  5. unstable or terminal physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia) or sleep disruptive medical condition (e.g. chronic pain)
  6. current use of medications known to cause insomnia (e.g., corticosteroids)
  7. 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)
  8. 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
  9. pregnant women or mothers with care-taking responsibilities for infants due to the sleep-disruption caused by such circumstances.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831894


Locations
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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206`
Sponsors and Collaborators
National Jewish Health
Investigators
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Principal Investigator: Jack D Edinger, Ph.D. National Jewish Health

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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT02831894    
Other Study ID Numbers: HS-2891
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Keywords provided by National Jewish Health:
insomnia
sedative hypnotics
hypnotic tapering
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs