Substance Use Disorder (SUD)NCT07503067
Identifying Substance Use Consequences
An observational study of Substance Use Disorder (SUD), run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder (SUD)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people with substance use disorders, their family members, and substance use disorder clinical providers
Who may be able to join
- (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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
R. Kathryn McHugh, PhD, 617-855-2000, kmchugh@mclean.harvard.edu
About this study
Official title: 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.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- none, there is no intervention in this study
- Keywords
- substance use disorder, measurement, patient reported outcomes
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none, there is no intervention in this studyOther
this is not an intervention study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: none, there is no intervention in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracted Themes
thematic analysis of qualitative interviews to extract common themes
Measured: same-day, single session
Thematic analysis
qualitative assessment using formal thematic analysis to extract common themes from qualitative interviews
Measured: single-session, same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start10 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, McHugh, R. Kathryn, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503067
- Sponsor's protocol ID
- 2025P000636
- Other IDs
- UG3DA062906
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only extracted themes will be shared as part of data sharing requirements from the study sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Measure of Substance-Related Consequences: A Novel Clinical Outcome Assessment for Substance Use Disorder Trials
- ClinicalTrials.gov ID
- NCT07503067
- Acronym / sponsor ID
- 2025P000636
- Conditions
- Substance Use Disorder (SUD)
- Keywords
- substance use disorder, measurement, patient reported outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| substance use disorder | – | Other: none, there is no intervention in this studypeople with lived experience with substance use disorder, a family member of someone with a substance use disorder or clinical provider treating substance use disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people with substance use disorders, their family members, and substance use disorder clinical providers
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none, there is no intervention in this studythis is not an intervention study | Other | substance use disorder |
Primary outcome
Extracted Themes
Time frame: same-day, single session
thematic analysis of qualitative interviews to extract common themes
Thematic analysis
Time frame: single-session, same day
qualitative assessment using formal thematic analysis to extract common themes from qualitative interviews
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. Only extracted themes will be shared as part of data sharing requirements from the study sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorder (SUD), run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact R. Kathryn McHugh, PhD (617-855-2000, kmchugh@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracted Themes (time frame: same-day, single session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.