The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation

Phase 2

Completed

• Conditions: Hypnotic Dependence Among Those With Insomnia
• Interventions: Drug: 0% Hypnotic Medication Taper; Drug: 25% Hypnotic Medication Taper; Drug: 10% Hypnotic Medication Taper

• Registration Number: NCT02831894
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-11-02
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Primary Completion: 2018-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0% Hypnotic Medication Taper	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.
25% Hypnotic Medication Taper	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.
10% Hypnotic Medication Taper	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.

Primary Outcome Measures

Name	Time	Method
Participant Dropout Rate As Assessed By Analysis of Participant Register	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	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

Name	Time	Method
Hypnotic Relapse Rate As Assessed by Analysis of Participant Reports	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.
Time to Drop Out of the Tapering Protocol As Assessed by Analysis of Participant Register	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.
Absolute Change/Reduction in Diazepam Equivalents of Medication Being Used Nightly As Assessed by Study Pharmaceutical Records	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.

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States