Measuring the consequences of substance use
Official title: Development and Validation of a Measure of Substance-Related Consequences: A Novel Clinical Outcome Assessment for Substance Use Disorder Trials
Run by Mclean Hospital · NCT07503067 · Data updated 2026-11-12
We will try a new questionnaire to measure treatment outcomes for people affected by substance use disorder, including patients, clinicians, and family members.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Status | Recruiting |
| Started | February 10, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT07503067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are English-literate adults who currently or previously received treatment for a substance use disorder, or who are clinicians, family members, or close friends with experience of such treatment.
✕Probably not a fit
People who cannot read English, who are acutely intoxicated, or who have major psychiatric or medical conditions that interfere with participation are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project aims to create a new patient-reported outcome measure of consequences related to substance use disorder. Researchers will conduct interviews and convene advisory groups of people with lived experience, family members, and clinicians to generate and refine questionnaire items. The team will use iterative feedback to develop clear, relevant survey items and plan further psychometric testing in later phases. All participation is conducted in English at McLean Hospital in Belmont, Massachusetts.
Why it matters
Potential benefit: If successful, the new questionnaire could provide clearer, patient-centered measures of treatment outcomes to guide clinical care and research.
How similar studies have gone: Using interviews and advisory panels to develop patient-reported outcome measures has been successful in other fields, though a validated SUD-specific consequences measure remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) ability to read and provide informed consent in English, and at least one of the following 2a) currently providing direct care to patients with substance use disorders, 2b) current or past treatment for an substance use disorder, or 2c) self-report of a close friend or family member who currently or previously received treatment for a substance use disorder. Exclusion Criteria: * 1\) major psychiatric or medical condition that would interfere with participation (e.g., acute psychosis, severe withdrawal); 2) current intoxication (positive breath alcohol test or behavioral evidence of other substance intoxication).
Where it's running
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McLean Hospital
Belmont, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: R. Kathryn McHugh, PhD
- Email: kmchugh@mclean.harvard.edu
- Phone: 617-855-2000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.