NCT07503067

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Jul 2027

Study Start

First participant enrolled

February 10, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 25, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

substance use disordermeasurementpatient reported outcomes

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

Interventions

this is not an intervention study

substance use disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • (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.

You may not qualify if:

  • \) 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Central Study Contacts

R. Kathryn McHugh, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 31, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Only extracted themes will be shared as part of data sharing requirements from the study sponsor.

Locations