NCT04938492

The Association Between Loneliness and Substance Use

Completed NA Results posted Last updated 11 February 2025

What this trial tests

NA trial testing Cognitive Behavioral Therapy for loneliness (CBT-L) in Opioid Use in 125 participants. Completed in 1 July 2023.

Timeline

12 August 2021

Primary endpoint
1 July 2023

1 July 2023

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	125
Start date	12 August 2021
Primary completion	1 July 2023
Estimated completion	1 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Cognitive Behavioral Therapy for loneliness (CBT-L)
• Physical Health Education Training (PHET)

Conditions studied

• Opioid Use — all drugs for Opioid Use →
• Loneliness — all drugs for Loneliness →

Sponsor

University of Rochester

Who can join

18 and older, any sex, with Opioid Use or Loneliness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Loneliness Primary · baseline to 2 months post-treatment

Loneliness will be measured using the University of California-Los Angeles (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.

Group	Value	95% CI
Cognitive Behavioral Therapy (CBT)	-8.3	± 14.9
Health Education	-10.3	± 12.5

Mean Change in Percent Days Abstinent From Opioids Secondary · baseline to 2 months post-treatment

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

Group	Value	95% CI
Cognitive Behavioral Therapy (CBT)	40	± 43
Health Education	20	± 30

Mean Change in Percent Days Abstinent From Other Drugs Secondary · baseline to 2 months

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

Group	Value	95% CI
Cognitive Behavioral Therapy (CBT)	30	± 42
Health Education	14	± 33

Mean Change in Social Support Secondary · baseline to 2 months post-treatment

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 or perceived social support. Scores range from 6 to 18.

Group	Value	95% CI
Cognitive Behavioral Therapy (CBT)	1.6	± 3.4
Health Education	1.0	± 3.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected over a period of approximately 4 months from baseline to 2-months post-treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitive Behavioral Therapy (CBT)

Serious: 0/63 (0%)

Deaths: 0/63

Health Education

Serious: 0/62 (0%)

Deaths: 0/62

Other adverse events (2 terms — click to expand)

Reaction	System	Cognitive Behavioral Thera…	Health Education
increase in psychiatric distress	Psychiatric disorders	—	—
drug withdrawal	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT04938492 adverse events section.

Sponsor's own description

The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized clinical trial to assess feasibility, acceptability and preliminary effects of telehealth-delivered cognitive-behavioral therapy for perceived social isolation among individuals with opioid use disorders.
   Ashrafioun L, Allan NP, Stecker TA. · · 2024 · cited 8× · PMID 38520791 · DOI 10.1016/j.drugalcdep.2024.111268