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NCT Number: NCT06458335

Intervening on Opioid Use and Loneliness

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.

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Key information

Conditions

Opioid Use Disorder Behavior Chemically-Induced Disorders Loneliness Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Social Behavior Social Isolation Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Lisham Ashrafioun, PhD

CONTACT

585-430-2026

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy for Perceived Social Isolation

Behavioral

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

Other names: CBT-PSI

Health Education

Behavioral

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

Primary outcomes

  1. Mean change in loneliness

    Time frame: Baseline to 6 months

    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.

  2. Mean change in number of days of opioid use

    Time frame: Baseline to 6 months

    Participants will complete a calendar indicating the type and frequency of drug use.

Secondary outcomes

  1. mean change in social interactions

    Time frame: Baseline to 6 months

    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.

  2. Mean change in depression

    Time frame: Baseline to 6 months

    Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

  3. Mean change in anxiety

    Time frame: Baseline to 6 months

    Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisham Ashrafioun, PhD

CONTACT

[email protected]

585-430-2026

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Medical University of South Carolina
  • National Institute on Drug Abuse (NIDA)
  • Ohio State University

Registry information

Official study title

Addressing Loneliness as a Therapy Target Among Individuals Using Opioids

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 13, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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