Health TrialsbyHealthPanel

Intervening on Opioid Use and Loneliness

ConditionsOpioid Use DisorderLonelinessSocial Isolation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must be 18+

understand English -have internet access-

screen positive for an opioid use disorder

screen positive for elevated loneliness

Disqualifiers

does not understand consent

does not have consistent access to a phone and internet

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Health Education

    Behavioral

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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Cognitive-Behavioral TherapyExperimental treatment 1 intervention
Group B: therapist-delivered Health EducationActive comparator 1 intervention
Group C: self-guided Health EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 6 months
2

Mean change in number of days of opioid use

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

Time frame
Baseline to 6 months

Secondary outcomes

1

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.

Time frame
Baseline to 6 months
2

Mean change in depression

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

Time frame
Baseline to 6 months
3

Mean change in anxiety

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

Time frame
Baseline to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Medical University of South Carolina

Collaborator

Ohio State University

Collaborator

Source ClinicalTrials.gov
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