Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05250570
Status:
TERMINATED
Last Update Posted:
2023-01-30
First Post:
2022-01-31
Brief Title:
Distress Tolerance for Benzodiazepine Discontinuation
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Distress Tolerance vs Relaxation Therapy for Benzodiazepine Discontinuation in Patients Receiving Opioid Agonist Therapy
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty with recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DT-BD
Brief Summary:
The proposed study is a clinical trial designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation DT-BD intervention for patients on opioid agonist therapy OAT who currently use benzodiazepines versus a Relaxation Therapy RT control condition The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue BZD use
Detailed Description:
This study pilot tests a 13-week distress tolerance-based psychosocial intervention paired with a benzodiazepine taper comparing it to a relaxation therapy control condition with the aim of assisting individuals receiving OAT discontinue benzodiazepine use All participants will receive the same benzodiazepine BZD discontinuation protocol The Distress Tolerance-Benzodiazepine Discontinuation DT-BD intervention consists of 13 weeks with 5 weekly therapy sessions prior to a 9-week BZD taper Some participants may be prescribed non-benzodiazepine medications to treat the underlying conditions for which they were using BZDs eg selective serotonin reuptake inhibitors SSRI for anxiety or hypnotics for insomnia Data collection will occur at baseline then weekly for 13 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 7K23DA044321-06 | NIH | None | httpsreporternihgovquickSearch7K23DA044321-06 |