Ignite Creation Date:
2024-05-06 @ 12:56 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01693978
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2012-09-21
Brief Title:
Contingency Outcomes in Prolonged Exposure
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Incentivizing Adherence to Prolonged Exposure With Substance Users
Status:
COMPLETED
Status Verified Date:
2016-08
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:
COPE
Brief Summary:
The aim of this research is to assess whether Contingency Management is effective in improving treatment adherence in substance use disordered SUD patients with comorbid PTSD Although Prolonged Exposure therapy PE is the gold standard treatment for PTSD the few studies of this treatment in substance users have shown poor adherence Contingency Management is a well-established approach that could be used to enhance adherence to PE From a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction Treatment Services an intent-to-treat sample of 62 patients with co-occurring current PTSD will be offered PE Half of the 62 participants will be randomly assigned to a Prolonged Exposure with Contingency Management PECM condition that provides monetary-based incentives for attending the PE therapy sessions The comparison condition will be assigned to a Prolonged Exposure PE condition without the attendance incentives intervention The PE sessions will be scheduled once per week for 12 weeks with a 12-week follow-up Groups will be compared primarily on adherence to the PE schedule improvement in PTSD symptoms and rates of drug use urine specimens self-reported use The studys three primary aims are to 1 Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to increase adherence in SUD patients in a methadone treatment program 2 Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD patients and 3 Evaluate the effect of PE for PTSD on rates of drug use in SUD patients
Detailed Description:
None
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