Intervening on Opioid Use and Loneliness

NCT ID: NCT06458335

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2029-06-30

Brief Summary

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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

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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.

Conditions

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Opioid Use Disorder Loneliness Social Isolation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Cognitive-Behavioral Therapy

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

Group Type EXPERIMENTAL

Cognitive-Behavioral Therapy for Perceived Social Isolation

Intervention Type BEHAVIORAL

6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use

therapist-delivered Health Education

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

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

Health education provides information on the importance and benefits of and guidelines for living a health lifestyle

self-guided Health Education

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

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

Health education provides information on the importance and benefits of and guidelines for living a health lifestyle

Interventions

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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

Intervention Type BEHAVIORAL

Health Education

Health education provides information on the importance and benefits of and guidelines for living a health lifestyle

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT-PSI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Lisham Ashrafioun

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lisham Ashrafioun, PhD

Role: CONTACT

585-430-2026

Facility Contacts

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Lisham Ashrafioun, PhD

Role: primary

585-430-2026

Other Identifiers

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1R01DA060966

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009396

Identifier Type: -

Identifier Source: org_study_id

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