Measuring the consequences of substance use
Development and Validation of a Measure of Substance-Related Consequences: A Novel Clinical Outcome Assessment for Substance Use Disorder Trials
Mclean Hospital · NCT07503067
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mclean Hospital (other) |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT07503067 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: R. Kathryn McHugh, PhD
- Email: kmchugh@mclean.harvard.edu
- Phone: 617-855-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Substance Use Disorder, substance use disorder, measurement, patient reported outcomes