Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156533
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2005-09-07
Brief Title:
Long Term Treatment With Zolpidem Nightly and Intermittent Dosing
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Long Term Treatment With Zolpidem The Relative Efficacy of Nightly Quaque Hora Somni QHS Intermittent Dosing and the Potential for Long Term Clinical Gains After Treatment Discontinuation
Status:
COMPLETED
Status Verified Date:
2015-10
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:
We want to assess whether how and when one takes sleep medication results in similar or different outcomes with respect to symptom relief We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped
Detailed Description:
To date the aggressive treatment Tx of chronic insomnia has been evaluated in terms of whether maintenance therapy is possible While what constitutes maintenance therapy is a matter of debate there are two studies which show that benzodiazepine receptor agonists BZRAs 1 are effective when used intermittently for up to 3 months and 2 may be used on a nightly basis for up to 6 months with no loss of efficacy
The significance of the present research is two fold First it will allow us to compare the two primary strategies used for long term treat of insomnia nightly dosing vs intermittent dosing Second it will allow an evaluation of the possibility that extended treatment given careful withdrawal from medication may yield long term clinical gains
Re Objective 1 It is widely assumed that intermittent dosing confers increased efficacy That is less frequent medication use will extend the duration of time for which the medication is maximally potent An empirical assessment of this proposition is required If incorrect physicians and patients should be encouraged to adopt a more aggressive approach to treatment If correct physicians and patients should be encouraged to adopt the intermittent dosing approach to treatment
Re Objective 2 It is widely assumed that treatment with sedatives sleep promoting medications constitutes only palliative care An empirical assessment of this proposition is required If correct physicians and patients should be encouraged to adopt a more aggressive approach to long term treatment If incorrect physicians and patients should be encouraged to adopt an approach to treatment that is not currently a standard of practice extended treatment with a clear plan to taper medication that is designed to maintain the clinical gains that occurred with medication use
We propose to evaluate the above issues in a pilot study of 40 subjects with Primary Insomnia where subjects are randomized to one of 4 conditions
1 QHS dosing with placebo
2 QHS dosing with 10mg of zolpidem
3 Intermittent dosing with 10mg of zolpidem 3-5 pills per week as needed
4 Monitor only condition
The significance of the present research is two fold First it will allow us to compare the two primary strategies used for long term treat of insomnia nightly dosing vs intermittent dosing Second it will allow an evaluation of the possibility that extended treatment given careful withdrawal from medication may yield long term clinical gains
Re Objective 1 It is widely assumed that intermittent dosing confers increased efficacy That is less frequent medication use will extend the duration of time for which the medication is maximally potent An empirical assessment of this proposition is required If incorrect physicians and patients should be encouraged to adopt a more aggressive approach to treatment If correct physicians and patients should be encouraged to adopt the intermittent dosing approach to treatment
Re Objective 2 It is widely assumed that treatment with sedatives sleep promoting medications constitutes only palliative care An empirical assessment of this proposition is required If correct physicians and patients should be encouraged to adopt a more aggressive approach to long term treatment If incorrect physicians and patients should be encouraged to adopt an approach to treatment that is not currently a standard of practice extended treatment with a clear plan to taper medication that is designed to maintain the clinical gains that occurred with medication use
We propose to evaluate the above issues in a pilot study of 40 subjects with Primary Insomnia where subjects are randomized to one of 4 conditions
1 QHS dosing with placebo
2 QHS dosing with 10mg of zolpidem
3 Intermittent dosing with 10mg of zolpidem 3-5 pills per week as needed
4 Monitor only condition
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11045 | OTHER | University of Rochester | None |