Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261183
Status:
UNKNOWN
Last Update Posted:
2005-12-02
First Post:
2005-12-01
Brief Title:
The Contribution of Melatonin Vs Placebo in Benzodiazepine Withdrawal in Methadone Maintenance Treatment Patients
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
RECRUITING
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 hypothesized that patient will success in benzodiazepine withdrawal if they get melatonin to solve sleep-problems which commonly occur during benzodiazepine withdrawal Former heroin addicts currently in Methadone maintenance treatment who are also abusing benzodiazepine started self benzodiazepine withdrawal and got for 6 weeks melatonin 5mgday taken every night or placebo and after 1 week additional 6 weeks with placebo or melatonin double blind for what got firstSuccess The benzodiazepine withdrawal success was evaluated by urine for benzodiazepines and sleep quality was evaluated using PSQI questionnaire baselineand after weeks 6 7 13
Detailed Description:
A total of 100 patients will participate Follow-up of benzodiazepines in urine after study and 6 months later will be evaluated as well as sleep quality using PSQI
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