Opioid Use Disorder Clinical Trial
Official title:
Addressing Loneliness as a Therapy Target Among Individuals Using Opioids
This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | June 30, 2029 |
Est. primary completion date | June 30, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Must be 18+ - understand English -have internet access- - screen positive for an opioid use disorder - screen positive for elevated loneliness Exclusion Criteria: - does not understand consent - does not have consistent access to a phone and internet |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Medical University of South Carolina, National Institute on Drug Abuse (NIDA), Ohio State University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in loneliness | Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome. | Baseline to 6 months | |
Primary | Mean change in number of days of opioid use | Participants will complete a calendar indicating the type and frequency of drug use. | Baseline to 6 months | |
Secondary | mean change in social interactions | Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions. Scores range from 0 to 37. | Baseline to 6 months | |
Secondary | Mean change in depression | Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome. | Baseline to 6 months | |
Secondary | Mean change in anxiety | Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome. | Baseline to 6 months |
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