Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253890
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2005-11-10
Brief Title:
Insomnia and Drug Relapse Risk
Sponsor:
Butler Hospital
Organization:
Butler Hospital
Study Overview
Official Title:
Insomnia and Drug Relapse Risk
Status:
COMPLETED
Status Verified Date:
2013-10
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:
The purposes of this study are
1 to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality as measured through polysomnography and
2 to evaluate the efficacy of trazodone as compared to placebo in individuals early in methadone maintenance
1 to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality as measured through polysomnography and
2 to evaluate the efficacy of trazodone as compared to placebo in individuals early in methadone maintenance
Detailed Description:
Individuals new to methadone maintenance will be asked to participate in this 6-month double-blind randomized control trial All participants will complete a baseline interview a medical screening and follow-up interviews at 1 3 and 6-months post-baseline These interviews take approximately 60 minutes and survey various areas of the participants experiences including basic demographic information mood sleep and substance use areas All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview Participants will also receive study medication half of the participants will receive a placebo medication and the other half will receive Trazodone a widely-prescribed well-tolerated low side-effect medication Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study This information can be available to the participant at the end of hisher study participation
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 |
|---|---|---|---|
| R01DA020479-01 | NIH | None | httpsreporternihgovquickSearchR01DA020479-01 |