Opioid UseNCT04938492
The Association Between Loneliness and Substance Use
A study testing Cognitive Behavioral Therapy for loneliness (CBT-L) and Physical Health Education Training (PHET) in people with Opioid Use and Loneliness, run by University of Rochester at 1 site in United States.
Trial summary
The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Loneliness
- What is being tested?
- Cognitive Behavioral Therapy for loneliness (CBT-L) and Physical Health Education Training (PHET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.
Read the detailed description
The proposed study will be the first to assess the cognitive, affective, and behavioral pathways by which loneliness impacts opioid use. Individuals with an opioid use disorder (OUD) reporting loneliness will be randomized to either a 6-session Cognitive- Behavioral Therapy for loneliness (CBT-L) or a 6-session education control condition, both delivered via telehealth. Telehealth delivery can be easily implemented and can increase reach and access to individuals not engaged in treatment. We will use an established brief CBT manual to address loneliness. We will assess loneliness, negative affect (i.e., depression and anxiety), and the quality and quantity of social interactions prior to, during, and after the intervention to evaluate the subsequent impact on opioid use trajectories. Participant will complete questionnaires pre-treatment, post-treatment, and at 1- and 2-months posttreatment.
- Conditions
- Opioid Use, Loneliness
- Being tested
- Cognitive Behavioral Therapy for loneliness (CBT-L), Physical Health Education Training (PHET)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for loneliness (CBT-L)Behavioural
6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
Physical Health Education Training (PHET)Behavioural
Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth. Receives: Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L) |
| Health Education | Active comparator | Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth. Receives: Behavioral: Physical Health Education Training (PHET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Loneliness
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.
Measured: baseline to 2 months post-treatment
Secondary outcomes (3)
Mean Change in Percent Days Abstinent From Opioids
Participants will complete a calendar indicating the type and frequency of drug use.
Measured: baseline to 2 months post-treatment
Mean Change in Percent Days Abstinent From Other Drugs
Participants will complete a calendar indicating the type and frequency of drug use.
Measured: baseline to 2 months
Mean Change in Social Support
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.
Measured: baseline to 2 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start12 Aug 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lisham Ashrafioun, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938492
- Sponsor's protocol ID
- STUDY00005387
- Status last verified
- Jan 2025
- First submitted
- 16 Jun 2021
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data is available upon request as part of scientific collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Loneliness and Substance Use
- ClinicalTrials.gov ID
- NCT04938492
- Acronym / sponsor ID
- STUDY00005387
- Conditions
- Opioid Use, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.
Detailed description
The proposed study will be the first to assess the cognitive, affective, and behavioral pathways by which loneliness impacts opioid use. Individuals with an opioid use disorder (OUD) reporting loneliness will be randomized to either a 6-session Cognitive- Behavioral Therapy for loneliness (CBT-L) or a 6-session education control condition, both delivered via telehealth. Telehealth delivery can be easily implemented and can increase reach and access to individuals not engaged in treatment. We will use an established brief CBT manual to address loneliness. We will assess loneliness, negative affect (i.e., depression and anxiety), and the quality and quantity of social interactions prior to, during, and after the intervention to evaluate the subsequent impact on opioid use trajectories. Participant will complete questionnaires pre-treatment, post-treatment, and at 1- and 2-months posttreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L)CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth. |
| Health Education | Active comparator | Behavioral: Physical Health Education Training (PHET)Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for loneliness (CBT-L)6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use. | Behavioural | Cognitive Behavioral Therapy (CBT) |
| Physical Health Education Training (PHET)Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle. | Behavioural | Health Education |
Primary outcome
Mean Change in Loneliness
Time frame: 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.
3 secondary outcomes
Mean Change in Percent Days Abstinent From Opioids
Time frame: baseline to 2 months post-treatment
Mean Change in Percent Days Abstinent From Other Drugs
Time frame: baseline to 2 months
Mean Change in Social Support
Time frame: baseline to 2 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Participant data is available upon request as part of scientific collaboration.
Related trials for Opioid Use
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for loneliness (CBT-L) and Physical Health Education Training (PHET) in people with Opioid Use and Loneliness, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Loneliness (time frame: baseline to 2 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.