Identifying Substance Use Consequences

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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorder (SUD)
• Intervention / Treatment: Other: none, there is no intervention in this study

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: R. Kathryn McHugh, PhD; Phone Number: 617-855-2000; Email: kmchugh@mclean.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Recruiting
      • McLean Hospital
      • Contact: R. Kathryn McHugh, PhD; Phone Number: 617-855-2000; Email: kmchugh@mclean.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

people with substance use disorders, their family members, and substance use disorder clinical providers

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
substance use disorder; people with lived experience with substance use disorder, a family member of someone with a substance use disorder or clinical provider treating substance use disorders	Other: none, there is no intervention in this study; this is not an intervention study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extracted Themes	thematic analysis of qualitative interviews to extract common themes	same-day, single session
Thematic analysis	qualitative assessment using formal thematic analysis to extract common themes from qualitative interviews	single-session, same day

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: patient reported outcomes; substance use disorder; measurement
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2025P000636; UG3DA062906 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only extracted themes will be shared as part of data sharing requirements from the study sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No