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Identifying Substance Use Consequences

Development and Validation of a Measure of Substance-Related Consequences: A Novel Clinical Outcome Assessment for Substance Use Disorder Trials

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07503067
Enrollment
50
Registered
2026-03-31
Start date
2026-02-10
Completion date
2027-07-31
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorder (SUD)

Keywords

substance use disorder, measurement, patient reported outcomes

Brief summary

The goal of this study is to develop a new tool for measuring substance use disorder treatment outcome. We will start by interviewing people and gathering advisory groups to develop the items for this new tool.

Interventions

OTHERnone, there is no intervention in this study

this is not an intervention study

Sponsors

Mclean Hospital
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Extracted Themessame-day, single sessionthematic analysis of qualitative interviews to extract common themes
Thematic analysissingle-session, same dayqualitative assessment using formal thematic analysis to extract common themes from qualitative interviews

Countries

United States

Contacts

CONTACTR. Kathryn McHugh, PhD
kmchugh@mclean.harvard.edu617-855-2000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026