N/A N=125 Randomized Treatment

The Association Between Loneliness and Substance Use

Opioid Use · Loneliness

Bottom Line

View on ClinicalTrials.gov: NCT04938492 ↗

Enrolled (actual)

125

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Mean Change in Loneliness — -8.3; -10.3 score on a scale — p=>.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive Behavioral Therapy for loneliness (CBT-L) (Behavioral); Physical Health Education Training (PHET) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Loneliness	-8.3; -10.3	>.05
SECONDARY Mean Change in Percent Days Abstinent From Opioids	40; 20	<.001 sig
SECONDARY Mean Change in Percent Days Abstinent From Other Drugs	30; 14	<.01 sig
SECONDARY Mean Change in Social Support	1.6; 1.0	>.05

Summary

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

Eligibility Criteria

Inclusion Criteria

Must be ages 18+
Understand English
Have internet access
Screen positive for an active OUD on the OUD Module of the Structured Clinical Interview for DSM-5 (Diagnostic & Statistical Manual of Mental Disorder, 5th edition) Research Version (SCID-5-RV)
Screen positive for loneliness by scoring at least a T-score > 60 on the NIH Toolbox Loneliness Scale

Exclusion Criteria

Consistent with previously used telehealth-delivered assessments, we will exclude any participant with cognitive impairment as measured by the Blessed Orientation-Memory-Concentration Test (BOMC)
Potential participants who are in the process of detoxifying as measured by the Subjective Opiate Withdrawal Scale will also be excluded

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04938492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.