Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients. (ISTOP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03212794|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder||Behavioral: Recovery coach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.|
|Actual Study Start Date :||February 11, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||June 2021|
Subjects randomized to the experimental arm will be assigned to a recovery coach.In addition to being linked to a community buprenorphine or methadone treatment program, the recovery coach will work to meet weekly with the subject following discharge from the hospital to provide support.
Behavioral: Recovery coach
The recovery coach will support the subjects in the following areas: 1) monitor and manage symptoms, 2) patient education and self-management, and 3) enlisting community and social supports. Encouragement to continue treatment will be a primary focus of the recovery coach. In addition, the coach will conduct weekly sessions on various topics and offer personal insights and facilitate a discussion.
No Intervention: Control
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.
- Treatment Retention [ Time Frame: 24 weeks after baseline ]Treatment retention in substance use disorder treatrment
- Illicit opioid use [ Time Frame: 24 weeks after baseline ]Number of days of illicit opioid use in the prior 30 days
- Readmissions [ Time Frame: 24 weeks after baseline ]Number of hospital readmissions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212794
|Contact: Joji Suzuki, MDemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Joji Suzuki, MD|
|Principal Investigator: Joji Suzuki, MD|
|Principal Investigator:||Joji Suzuki, MD||Brigham and Women's Hospital|