Alcohol MisuseNCT07070414
Substance Use in Assault-Injured Young Adults
A study testing Brief Negotiation Interview intervention (BNI) (adapted) in people with Alcohol Misuse and Cannabis Misuse, run by Yale University at 1 site in United States.
Trial summary
This study aims to improve a short motivational conversation to better help young adults who were injured in assaults and also use alcohol or cannabis. Researchers will gather both interview and survey data from young adults who came to the emergency department after an assault and currently use alcohol or cannabis. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Misuse, Cannabis Misuse
- What is being tested?
- Brief Negotiation Interview intervention (BNI) (adapted)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Feb 2028
- Phase
- Interventional
- 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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aim 1:
- Be clients of the Yale Hospital Violence Intervention Program (YHVIP)
- Be between the ages of 18-25 y/o upon study enrollment
- Have sustained an intentional injury inflicted by another person not considered to be a boy/girlfriend, fiancée, or spouse in the past year
- Report current alcohol and/or cannabis misuse
- Be English-speaking and able to provide informed consent.
Show all 11Show fewer
- Aim 2 and 3:
- Present to Yale New Haven Hospital ED for an intentional injury inflicted by another person not considered to be a boy/girlfriend, fiancée, or spouse
- Be between the ages of 18-25 y/o upon study enrollment
- Report current alcohol and/or cannabis misuse
- Be English-speaking and able to provide informed consent.
Who cannot join
- Aim 1:
- Be actively suicidal or severely cognitively impaired precluding informed consent
- Sustain an intentional injury from a boy/girlfriend, fiancée, or spouse or sexual assault
- Be incarcerated or in police custody
- Currently engaged in addiction treatment
- Aim 2 and 3:
Show all 10Show fewer
- Be actively suicidal or severely cognitively impaired precluding informed consent
- Sustain intentional injury from a boy/girlfriend, fiancée, spouse or by sexual assault
- Be incarcerated or in police custody
- Currently engaged in addiction treatment
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
Yale Department of Emergency Medicine
New Haven, Connecticut, 06520
About this study
Official title: Alcohol and Cannabis Use Among Assault-Injured Emerging Adults
This study aims to improve a short motivational conversation to better help young adults who were injured in assaults and also use alcohol or cannabis. Researchers will gather both interview and survey data from young adults who came to the emergency department after an assault and currently use alcohol or cannabis. Guided by a theory about risky behaviors, the study will focus on how confident young people feel about making changes to their alcohol and cannabis use, and how their friends and family influence their alcohol and cannabis use and involvement in injuries from assault. The team will follow a step-by-step process used by the NIH to adapt and test the improved motivational conversation in the emergency department.
Read the detailed description
Aim 1: Quantitatively and qualitatively assess self-efficacy, perceived peer and familial norms, and motivation to reduce alcohol and/or cannabis use and engage in treatment referral, among assault-injured emerging adults. AIM 2: Adapt the BNI for use among assault-injured emerging adults with alcohol and/or cannabis misuse in the ED. AIM 3: Determine the feasibility and acceptability of an adapted BNI among assault-injured emerging adults with alcohol and/or cannabis misuse presenting to the ED through a randomized pilot trial comparing those who have received the adapted BNI and treatment referrals to a referrals-only control group. The focus of this registration is the randomized pilot in Aim 3. Anticipated start dates will be reflected in the clinical trial component in Aim 3.
- Conditions
- Alcohol Misuse, Cannabis Misuse
- Being tested
- Brief Negotiation Interview intervention (BNI) (adapted)
- Keywords
- alcohol misuse, cannabis misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Negotiation Interview intervention (BNI) (adapted)Behavioural
A brief motivational interview designed to increase motivation to reduce alcohol and/or cannabis use and engagement in treatment referral.
| Study group | Role | What they receive |
|---|---|---|
| Brief Negotiation Interview intervention (BNI) (adapted) | Experimental | Participants randomized to the intervention arm will receive a brief motivational interview designed to increase motivation to reduce alcohol and/or cannabis use and engagement in treatment referral at 30-days. A referral includes a contact number to addiction treatment (primary care and/or specialty addiction care consistent with diagnostic criteria) and injury prevention services at the Yale Hospital Violence Intervention Program. Receives: Behavioral: Brief Negotiation Interview intervention (BNI) (adapted) |
| Control Group | No intervention | Control group will receive contact referrals only. A referral includes a contact number to addiction treatment (primary care and/or specialty addiction care consistent with diagnostic criteria) and injury prevention services at the Yale Hospital Violence Intervention Program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by recruitment
Recruitment measured as the percentage of those invited/those who enrolled
Measured: Day 0 and 30
Feasibility assessed by randomization
Recruitment measured as the percentage of screened eligible participants who enroll/those who receive either intervention or control arm
Measured: Day 0 and 30
Feasibility assessed by retention
Recruitment measured as the percentage of those enrolled who have received either intervention or control arm/ participants who have completed all 30-day follow up assessments
Measured: Day 0 and 30
Acceptability assessed by Acceptability of Intervention Measure (AIM)
Acceptability of the intervention will be assessed using the Acceptability of Intervention Measure (AIM). It has 4-items scored on a 5-point Likert scale summed to achieve a total score. Total score range of 0-20. Higher scores indicate more acceptability.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study startMar 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Edouard Coupet, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070414
- Sponsor's protocol ID
- 2000040490
- Other IDs
- 1R34DA061051-01A1
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual-level data will be shared 6 months after publication for up to 3 years
Publications
Coupet E Jr, Dodington J, D'Onofrio G, Stover CS, Dziura J, Vega CP, Couvertier E, Latham E, Gawel M, Fiellin DA, Fretz SL, Vaca FE. An adapted brief negotiation interview for alcohol and cannabis use among assault-injured emerging adults: A randomized pilot trial protocol. Contemp Clin Trials. 2026 May;164:108287. doi: 10.1016/j.cct.2026.108287. Epub 2026 Mar 14.
PubMed 41839387
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and Cannabis Use Among Assault-Injured Emerging Adults
- ClinicalTrials.gov ID
- NCT07070414
- Acronym / sponsor ID
- 2000040490
- Conditions
- Alcohol Misuse, Cannabis Misuse
- Keywords
- alcohol misuse, cannabis misuse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 17 Jul 2025 (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.
This study aims to improve a short motivational conversation to better help young adults who were injured in assaults and also use alcohol or cannabis. Researchers will gather both interview and survey data from young adults who came to the emergency department after an assault and currently use alcohol or cannabis. Guided by a theory about risky behaviors, the study will focus on how confident young people feel about making changes to their alcohol and cannabis use, and how their friends and family influence their alcohol and cannabis use and involvement in injuries from assault. The team will follow a step-by-step process used by the NIH to adapt and test the improved motivational conversation in the emergency department.
Detailed description
Aim 1: Quantitatively and qualitatively assess self-efficacy, perceived peer and familial norms, and motivation to reduce alcohol and/or cannabis use and engage in treatment referral, among assault-injured emerging adults. AIM 2: Adapt the BNI for use among assault-injured emerging adults with alcohol and/or cannabis misuse in the ED. AIM 3: Determine the feasibility and acceptability of an adapted BNI among assault-injured emerging adults with alcohol and/or cannabis misuse presenting to the ED through a randomized pilot trial comparing those who have received the adapted BNI and treatment referrals to a referrals-only control group. The focus of this registration is the randomized pilot in Aim 3. Anticipated start dates will be reflected in the clinical trial component in Aim 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Negotiation Interview intervention (BNI) (adapted) | Experimental | Behavioral: Brief Negotiation Interview intervention (BNI) (adapted)Participants randomized to the intervention arm will receive a brief motivational interview designed to increase motivation to reduce alcohol and/or cannabis use and engagement in treatment referral at 30-days. A referral includes a contact number to addiction treatment (primary care and/or specialty addiction care consistent with diagnostic criteria) and injury prevention services at the Yale Hospital Violence Intervention Program. |
| Control Group | No intervention | –Control group will receive contact referrals only. A referral includes a contact number to addiction treatment (primary care and/or specialty addiction care consistent with diagnostic criteria) and injury prevention services at the Yale Hospital Violence Intervention Program. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Be clients of the Yale Hospital Violence Intervention Program (YHVIP)
- Be between the ages of 18-25 y/o upon study enrollment
- Have sustained an intentional injury inflicted by another person not considered to be a boy/girlfriend, fiancée, or spouse in the past year
- Report current alcohol and/or cannabis misuse
- Be English-speaking and able to provide informed consent.
Key exclusion criteria (10 listed)
- Be actively suicidal or severely cognitively impaired precluding informed consent
- Sustain an intentional injury from a boy/girlfriend, fiancée, or spouse or sexual assault
- Be incarcerated or in police custody
- Currently engaged in addiction treatment
- Be actively suicidal or severely cognitively impaired precluding informed consent
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 |
|---|---|---|
| Brief Negotiation Interview intervention (BNI) (adapted)A brief motivational interview designed to increase motivation to reduce alcohol and/or cannabis use and engagement in treatment referral. | Behavioural | Brief Negotiation Interview intervention (BNI) (adapted) |
Primary outcome
Feasibility assessed by recruitment
Time frame: Day 0 and 30
Recruitment measured as the percentage of those invited/those who enrolled
Feasibility assessed by randomization
Time frame: Day 0 and 30
Recruitment measured as the percentage of screened eligible participants who enroll/those who receive either intervention or control arm
Feasibility assessed by retention
Time frame: Day 0 and 30
Recruitment measured as the percentage of those enrolled who have received either intervention or control arm/ participants who have completed all 30-day follow up assessments
Acceptability assessed by Acceptability of Intervention Measure (AIM)
Time frame: Day 0
Acceptability of the intervention will be assessed using the Acceptability of Intervention Measure (AIM). It has 4-items scored on a 5-point Likert scale summed to achieve a total score. Total score range of 0-20. Higher scores indicate more acceptability.
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 4 Jun 2026.
- Derived from this study: PubMed 41839387Coupet E Jr, Dodington J, D'Onofrio G, Stover CS, Dziura J, Vega CP, Couvertier E, Latham E, Gawel M, Fiellin DA, Fretz SL, Vaca FE. An adapted brief negotiation interview for alcohol and cannabis use among assault-injured emerging adults: A randomized pilot trial protocol. Contemp Clin Trials. 2026 May;164:108287. doi: 10.1016/j.cct.2026.108287. Epub 2026 Mar 14.
- Individual participant dataSharing planned: Yes. De-identified individual-level data will be shared 6 months after publication for up to 3 years
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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.
Edouard Coupet, MD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Negotiation Interview intervention (BNI) (adapted) in people with Alcohol Misuse and Cannabis Misuse, run by Yale University 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 11 inclusion and 10 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: opening soon, as of the sponsor's last update on 4 Jun 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 Edouard Coupet Jr., MD, MS ((203) 584-9445, edouard.coupet@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by recruitment (time frame: Day 0 and 30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07070414, which also lists 1 linked publication.
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 4 Jun 2026.