Substance UseNCT03308877
Brief Intervention for Justice-Involved Substance Users
A study testing BMI and Stadard Care (SC) in people with Substance Use and Violence, run by University of Rochester at 2 sites in United States.
Trial summary
This is a randomized clinical trial to study ways of helping justice-involved people change to more healthy behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use, Violence
- What is being tested?
- BMI and Stadard Care (SC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2018to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- In Monroe County Pretrial Services Program
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pretrial Services, Inc.
Rochester, New York, 14642
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Brief Intervention for Justice-Involved Substance Users: Moderators and Mechanisms of Change
This is a randomized clinical trial to study ways of helping justice-involved people change to more healthy behavior.
- Conditions
- Substance Use, Violence
- Being tested
- BMI, Stadard Care (SC)
- 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.
BMIBehavioural
Four 45-minute, brief motivational sessions for substance use
Stadard Care (SC)Behavioural
Standard procedures at pretrial program + assessement
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Intervention (BMI) | Experimental | Not described Receives: Behavioral: BMI; Behavioral: Stadard Care (SC) |
| Standard Care (SC) | Active comparator | Not described Receives: Behavioral: Stadard Care (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Days Abstinent
Percent Days not using alcohol or drugs
Measured: 6 months
Substance Use Consequences (SIP-AD)
Short Inventory of Problems with Alcohol or Drugs (SIP-AD) Range 0-45 higher = more problems
Measured: 6 months
Violent Charges
Number of violent charges during follow-up from Statewide Database
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start1 Feb 2018
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance UseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Marc Swogger, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308877
- Sponsor's protocol ID
- RSRB69167
- Other IDs
- R01DA043660
- Status last verified
- Mar 2025
- First submitted
- 9 Oct 2017
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention for Justice-Involved Substance Users: Moderators and Mechanisms of Change
- ClinicalTrials.gov ID
- NCT03308877
- Acronym / sponsor ID
- RSRB69167
- Conditions
- Substance Use, Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial to study ways of helping justice-involved people change to more healthy behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Intervention (BMI) | Experimental | Behavioral: BMI, Behavioral: Stadard Care (SC) |
| Standard Care (SC) | Active comparator | Behavioral: Stadard Care (SC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In Monroe County Pretrial Services Program
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| BMIFour 45-minute, brief motivational sessions for substance use | Behavioural | Brief Motivational Intervention (BMI) |
| Stadard Care (SC)Standard procedures at pretrial program + assessement | Behavioural | Brief Motivational Intervention (BMI), Standard Care (SC) |
Primary outcome
Percent Days Abstinent
Time frame: 6 months
Percent Days not using alcohol or drugs
Substance Use Consequences (SIP-AD)
Time frame: 6 months
Short Inventory of Problems with Alcohol or Drugs (SIP-AD) Range 0-45 higher = more problems
Violent Charges
Time frame: 2 years
Number of violent charges during follow-up from Statewide Database
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMI and Stadard Care (SC) in people with Substance Use and Violence, run by University of Rochester at 2 sites 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: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Days Abstinent (time frame: 6 months). The study lists 3 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 18 Mar 2025.