Intervening on Opioid Use and Loneliness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive-Behavioral Therapy for Perceived Social Isolation, Health Education.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, Loneliness, Social Isolation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Addressing Loneliness as a Therapy Target Among Individuals Using Opioids
Overview
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.
Detailed description
Individuals (n = 300) with an opioid use disorder reporting loneliness will be randomized to either (1) therapist-delivered cognitive-behavioral therapy for perceived social isolation, (2) therapist-delivered Health Education, or (3) self-guided Health Education. Loneliness, opioid and other substance use, the amount of social interactions, social support, and mental and physical health factors prior to starting the treatment, after completing the treatment, and 1, 3, and 6 months following the treatment will be assessed to see how well they work compared to each other.
Interventions
- Behavioral Cognitive-Behavioral Therapy for Perceived Social Isolation
6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use - Behavioral Health Education
Health education provides information on the importance and benefits of and guidelines for living a health lifestyle
Primary outcome measures
- Mean change in loneliness [Time frame: Baseline to 6 months]
- Mean change in number of days of opioid use [Time frame: Baseline to 6 months]
Secondary outcome measures (3)
- mean change in social interactions [Time frame: Baseline to 6 months]
- Mean change in depression [Time frame: Baseline to 6 months]
- Mean change in anxiety [Time frame: Baseline to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Rochester — Rochester
Identifiers
NCT: NCT06458335 · STUDY00009396 · 1R01DA060966