Substance AbuseNCT07140276
An Integrated Substance Abuse-Domestic Violence (SADV) Treatment Outcome Study
A study testing Individual Therapy and Individual Drug Counseling manual in people with Substance Abuse and Domestic Violence, run by Yale University at 1 site in United States.
Trial summary
Investigators will conduct a randomized trial comparing individual SADV to a manualized comparison condition that focuses on substance use only. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Substance Abuse, Domestic Violence
- What is being tested?
- Individual Therapy and Individual Drug Counseling manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2007to 30 Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referred by the courts or probation for treatment of substance use and domestic violence and who
- meet current DSM-IV criteria for substance dependence (alcohol, cocaine and marijuana, and who have used that substance within the 30 days prior to the screening session)
- report physical violence in an intimate relationship (pushing, slapping, kicking) within 30 days prior to screening
- can read English at a 6th grade level.
Who cannot join
- Currently in withdrawal from substances and in need of detoxification (such individuals may be re-evaluated following detoxification)
- Have cognitive impairment (a mini mental state score <25)
- Have psychomotor epilepsy (e.g. impulsivity or rage related symptoms secondary to a seizure disorder, as this medical diagnosis is likely to be a confound in the proposed study)
- Have major medical complications such as a head injury/trauma, or HIV dementia that may also be a confound in the study interventions
- Currently receiving either substance abuse or IPV treatment elsewhere
- Have a lifetime history of any psychotic or bipolar disorder
- Currently suicidal or homicidal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Health System
New Haven, Connecticut, 06511
About this study
Official title: An Integrated Substance Abuse-Domestic Violence (SADV) Treatment Outcome Study: A Stage 1 Trial for SADV
Investigators will conduct a randomized trial comparing individual SADV to a manualized comparison condition that focuses on substance use only.
Read the detailed description
The randomized trial will be informed by previous work developing and refining the interventions and training materials used in the randomized trial.
The focus of this registration is the randomized trial.
- Conditions
- Substance Abuse, Domestic Violence
- Being tested
- Individual Therapy, Individual Drug Counseling manual
- 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.
Individual TherapyBehavioural
12 weeks individual psychotherapy
Individual Drug Counseling manualBehavioural
12 weeks using the manual provided
| Study group | Role | What they receive |
|---|---|---|
| Individual SADV Therapy | Experimental | Men referred from court and probation for treatment of substance use and domestic violence related problems will receive 12 weeks of individual therapy that focuses on SADV. Receives: Behavioral: Individual Therapy |
| Manualized comparison condition | Experimental | Men referred from court and probation for treatment of substance use and domestic violence related problems will receive 12 weeks of therapy using the manual provided that focuses on substance use only. Receives: Behavioral: Individual Drug Counseling manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Days of substance use
Days of substance use weekly from each participant endorsed as Y/N, by Self-report using time line follow back method, verified by alcohol concentration and urine toxicology
Measured: Weekly up to 12 weeks
Mean Days of physical violence use
Days of physical violence use weekly from each participant endorsed as Y/N, by Self-report using time line follow back method, verified by female collateral informant
Measured: Weekly up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start3 Jul 2007
- Primary completion30 Jun 2010
- Study completion30 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Men referred by the courts or probation for treatment of substance use who have domestic violence related problems.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Caroline Easton, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140276
- Sponsor's protocol ID
- 10492
- Other IDs
- RDA018284A
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Substance Abuse-Domestic Violence (SADV) Treatment Outcome Study: A Stage 1 Trial for SADV
- ClinicalTrials.gov ID
- NCT07140276
- Acronym / sponsor ID
- 10492
- Conditions
- Substance Abuse, Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Jul 2007 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 24 Aug 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.
Investigators will conduct a randomized trial comparing individual SADV to a manualized comparison condition that focuses on substance use only.
Detailed description
The randomized trial will be informed by previous work developing and refining the interventions and training materials used in the randomized trial.
The focus of this registration is the randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Men referred by the courts or probation for treatment of substance use who have domestic violence related problems.
| Arm | Type | Receives |
|---|---|---|
| Individual SADV Therapy | Experimental | Behavioral: Individual TherapyMen referred from court and probation for treatment of substance use and domestic violence related problems will receive 12 weeks of individual therapy that focuses on SADV. |
| Manualized comparison condition | Experimental | Behavioral: Individual Drug Counseling manualMen referred from court and probation for treatment of substance use and domestic violence related problems will receive 12 weeks of therapy using the manual provided that focuses on substance use only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- referred by the courts or probation for treatment of substance use and domestic violence and who
- meet current DSM-IV criteria for substance dependence (alcohol, cocaine and marijuana, and who have used that substance within the 30 days prior to the screening session)
- report physical violence in an intimate relationship (pushing, slapping, kicking) within 30 days prior to screening
- can read English at a 6th grade level.
Key exclusion criteria (7 listed)
- Currently in withdrawal from substances and in need of detoxification (such individuals may be re-evaluated following detoxification)
- Have cognitive impairment (a mini mental state score <25)
- Have psychomotor epilepsy (e.g. impulsivity or rage related symptoms secondary to a seizure disorder, as this medical diagnosis is likely to be a confound in the proposed study)
- Have major medical complications such as a head injury/trauma, or HIV dementia that may also be a confound in the study interventions
- Currently receiving either substance abuse or IPV treatment elsewhere
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 |
|---|---|---|
| Individual Therapy12 weeks individual psychotherapy | Behavioural | Individual SADV Therapy |
| Individual Drug Counseling manual12 weeks using the manual provided | Behavioural | Manualized comparison condition |
Primary outcome
Mean Days of substance use
Time frame: Weekly up to 12 weeks
Days of substance use weekly from each participant endorsed as Y/N, by Self-report using time line follow back method, verified by alcohol concentration and urine toxicology
Mean Days of physical violence use
Time frame: Weekly up to 12 weeks
Days of physical violence use weekly from each participant endorsed as Y/N, by Self-report using time line follow back method, verified by female collateral informant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Substance Abuse
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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.
Caroline Easton, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Therapy and Individual Drug Counseling manual in people with Substance Abuse and Domestic Violence, 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 4 inclusion and 7 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 24 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Days of substance use (time frame: Weekly up to 12 weeks). 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 24 Aug 2025.