Ignite Creation Date:
2024-05-06 @ 8:50 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02831894
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2016-05-13
Brief Title:
The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation
Sponsor:
National Jewish Health
Organization:
National Jewish Health
Study Overview
Official Title:
The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None