Intervening on Opioid Use and Loneliness

University of Rochester

Status: Enrolling

Conditions: Opioid Use Disorder; Loneliness; Social Isolation

Treatments: Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation; Behavioral: Health Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06458335

1R01DA060966 (U.S. NIH Grant/Contract)

STUDY00009396

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Cognitive-Behavioral Therapy

Experimental group

Description:

CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth

Treatment:

Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation

therapist-delivered Health Education

Active Comparator group

Description:

Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.

Treatment:

Behavioral: Health Education

self-guided Health Education

Active Comparator group

Description:

Health education sessions that are self-guided over the course of 6 sessions

Treatment:

Behavioral: Health Education