Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102200
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-08-31
Brief Title:
An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder
Sponsor:
Prisma Health-Upstate
Organization:
Prisma Health-Upstate
Study Overview
Official Title:
Prisma Health Clemson University
Status:
RECRUITING
Status Verified Date:
2023-10
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:
OVERCOME 2
Brief Summary:
The Overcome II study is a randomized controlled trial among adults receiving sublingual buprenorphine to help prevent or reduce illicit drug use The study outcomes will be compared between three treatment arms 1 sublingual buprenorphine only which is the standard-of-treatment 2 sublingual buprenorphine with a computer-based cognitive behavior therapy for substance use disorders CBT4CBT 3 sublingual buprenorphine with CBT4CBT and peer recovery coaching The primary outcome of interest is the reduction in the proportion of positive results for saliva toxicology screenings for any drug during the 8-week treatment period Study participants will also be assessed for the outcomes of retention to standard-of-treatment and illicit drug use at 1- 3- and 6-months follow-ups after the end of treatment
Detailed Description:
Buprenorphine has proven to be an effective pharmacologic strategy for treating OUD However buprenorphine is unlikely to give greater overall protection because of the shorter duration of treatment There is a need for studies on interventions that could increase retention to buprenorphine especially among those with ongoing illicit substance and polysubstance use
Using a randomized controlled trial study design the Overcome II study aims to investigate the incremental benefit in terms of reduction in illicit drug use and retention in standard of treatment due to providing the peer recovery coach andor CBT4CBT interventions as a compliment to standard-of-treatment among persons receiving medication for opioid use The study outcomes will be compared between three treatment arms 1 sublingual buprenorphine only which is the standard-of-treatment 2 sublingual buprenorphine with CBT4CBT 3 sublingual buprenorphine with CBT4CBT and peer recovery coaching The primary outcome of interest is reduction in the proportion of positive results for saliva toxicology screenings for any drug during the 8-week treatment period Study participants will also be assessed for the outcomes of retention to standard-of-treatment and illicit drug use at 1- 3- and 6-months follow-ups after the end of treatment The institutional review board at Prisma Health will provide the oversight for the ethical conduct of the study Potential participants at Prisma Health will be screened for eligibility will undergo the informed consent procedure and eligible persons who consent to participation will be recruited into the study
The participants will be randomized of one of the three treatment arms in a 111 ratio The study will aim to recruit 30 participants per treatment arm Study procedures will be conducted both virtually and at research facilities of the Prisma Health Addiction Medicine Center in Greenville SC Participants will attend the research visits once a week during the first eight weeks sessions 1 to 8 and 1- 3- and 6- months after the end of treatment
Using a randomized controlled trial study design the Overcome II study aims to investigate the incremental benefit in terms of reduction in illicit drug use and retention in standard of treatment due to providing the peer recovery coach andor CBT4CBT interventions as a compliment to standard-of-treatment among persons receiving medication for opioid use The study outcomes will be compared between three treatment arms 1 sublingual buprenorphine only which is the standard-of-treatment 2 sublingual buprenorphine with CBT4CBT 3 sublingual buprenorphine with CBT4CBT and peer recovery coaching The primary outcome of interest is reduction in the proportion of positive results for saliva toxicology screenings for any drug during the 8-week treatment period Study participants will also be assessed for the outcomes of retention to standard-of-treatment and illicit drug use at 1- 3- and 6-months follow-ups after the end of treatment The institutional review board at Prisma Health will provide the oversight for the ethical conduct of the study Potential participants at Prisma Health will be screened for eligibility will undergo the informed consent procedure and eligible persons who consent to participation will be recruited into the study
The participants will be randomized of one of the three treatment arms in a 111 ratio The study will aim to recruit 30 participants per treatment arm Study procedures will be conducted both virtually and at research facilities of the Prisma Health Addiction Medicine Center in Greenville SC Participants will attend the research visits once a week during the first eight weeks sessions 1 to 8 and 1- 3- and 6- months after the end of treatment
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34DA057662 | NIH | None | httpsreporternihgovquickSearchR34DA057662 |