The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation
| Status: | Suspended |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/22/2019 |
| Start Date: | August 2015 |
| End Date: | August 2019 |
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 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. A sizable proportion of 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. Previous research provides only a
rudimentary understanding of how to help long-term hypnotic users discontinue their sleep
aids and successfully manage their insomnia with CBT-I techniques.
Limitations of existing research include failure to consider how:
1. the pace of hypnotic withdrawal influences outcomes;
2. patient characteristics such as belief in the need for sleep medications, and anxiety
sensitivity moderate outcomes; and
3. hypnotic withdrawal symptoms and changes in sleep quality mediate outcomes.
This R34 project will gather key pilot data to address these limitations. Specifically, this
project will compare the currently recommended tapering pace (25% dose reduction every two
weeks) to a slower tapering pace (10% dose reduction every two weeks) and a no tapering
condition to determine the influence of tapering pace on outcomes. The study also will
examine participants' beliefs about their need for hypnotics, anxiety sensitivity, and
hypnotic dose, half-life and time used as moderators of outcomes. The influence of hypnotic
withdrawal symptoms and level of sleep disturbance during withdrawal will be tested as
mediators of outcomes. Enrollees (N=75) will first complete CBT-I and then will be randomized
to a tapering pace (n=25 per SMT pace). Target moderators and mediators will be examined to
assess their influence on outcomes. Primary outcomes will include drop-out rates and hypnotic
discontinuation rates observed for each SMT pace. Investigators will tally rates of those who
achieve hypnotic dose reductions during SMT and those who return to hypnotic use by a 3-month
follow-up as secondary endpoints. Results will inform a future R01-level clinical trial
focusing on tapering pace, patient characteristics that moderate the effect of tapering pace,
and psychophysiological processes that mediate the effect of tapering pace. This line of
research will inform clinical practice by helping to refine guidelines for tapering pace so
as to provide more successful, person-centered interventions
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 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. A sizable proportion of 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. Previous research provides only a
rudimentary understanding of how to help long-term hypnotic users discontinue their sleep
aids and successfully manage their insomnia with CBT-I techniques.
Limitations of existing research include failure to consider how:
1. the pace of hypnotic withdrawal influences outcomes;
2. patient characteristics such as belief in the need for sleep medications, and anxiety
sensitivity moderate outcomes; and
3. hypnotic withdrawal symptoms and changes in sleep quality mediate outcomes.
This R34 project will gather key pilot data to address these limitations. Specifically, this
project will compare the currently recommended tapering pace (25% dose reduction every two
weeks) to a slower tapering pace (10% dose reduction every two weeks) and a no tapering
condition to determine the influence of tapering pace on outcomes. The study also will
examine participants' beliefs about their need for hypnotics, anxiety sensitivity, and
hypnotic dose, half-life and time used as moderators of outcomes. The influence of hypnotic
withdrawal symptoms and level of sleep disturbance during withdrawal will be tested as
mediators of outcomes. Enrollees (N=75) will first complete CBT-I and then will be randomized
to a tapering pace (n=25 per SMT pace). Target moderators and mediators will be examined to
assess their influence on outcomes. Primary outcomes will include drop-out rates and hypnotic
discontinuation rates observed for each SMT pace. Investigators will tally rates of those who
achieve hypnotic dose reductions during SMT and those who return to hypnotic use by a 3-month
follow-up as secondary endpoints. Results will inform a future R01-level clinical trial
focusing on tapering pace, patient characteristics that moderate the effect of tapering pace,
and psychophysiological processes that mediate the effect of tapering pace. This line of
research will inform clinical practice by helping to refine guidelines for tapering pace so
as to provide more successful, person-centered interventions
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.
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