Substance Use DisordersPhase 1/2NCT00551863
Developing Violence Prevention Therapy for Substance Abusers
A Phase 1/2 study testing IVPT in people with Substance Use Disorders and Violence, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this project is to develop and pilot test a violence prevention intervention for men and women in treatment for substance use problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Violence
- What is being tested?
- IVPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Mar 2008
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of substance use related problems
- Interpersonal Violence history in the year before recruitment
Who cannot join
- Primary opiate dependence
- Presence of active psychotic disorder
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Violence Therapy for Substance Abusers
The purpose of this project is to develop and pilot test a violence prevention intervention for men and women in treatment for substance use problems.
- Conditions
- Substance Use Disorders, Violence
- Being tested
- IVPT
- Keywords
- alcohol, drugs, aggression, substance use disorder treatment
- Medical subject headings
- Substance-Related Disorders, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVPTBehavioural
Violence prevention intervention based on Motivational Interviewing and CBT
| Study group | Role | What they receive |
|---|---|---|
| IVPT | Active comparator | Intervention based on Motivational Interviewing and CBT Receives: Behavioral: IVPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal Violence
Measured: 3 and 6 month follow-up
Secondary outcomes (1)
alcohol and drug use
Measured: 3 and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startJun 2004
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Stephen Chermack, University of Michigan
- Investigators
- Stephen T Chermack, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551863
- Sponsor's protocol ID
- R01DA017295-01A1
- Other IDs
- R01DA017295
- Status last verified
- Aug 2015
- First submitted
- 30 Oct 2007
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Epstein-Ngo QM, Walton MA, Sanborn M, Kraus S, Blow F, Cunningham R, Chermack ST. Distal and proximal factors associated with aggression towards partners and non-partners among patients in substance abuse treatment. J Subst Abuse Treat. 2014 Oct;47(4):282-92. doi: 10.1016/j.jsat.2014.05.005. Epub 2014 Jun 10.
PubMed 25012548Ilgen MA, Chermack ST, Murray R, Walton MA, Barry KL, Wojnar M, Blow FC. The association between partner and non-partner aggression and suicidal ideation in patients seeking substance use disorder treatment. Addict Behav. 2009 Feb;34(2):180-6. doi: 10.1016/j.addbeh.2008.10.004. Epub 2008 Oct 10.
PubMed 18977093Chermack ST, Murray RL, Winters JJ, Walton MA, Booth BM, Blow FC. Treatment needs of men and women with violence problems in substance use disorder treatment. Subst Use Misuse. 2009;44(9-10):1236-62. doi: 10.1080/10826080902960007.
PubMed 19938916Murray RL, Chermack ST, Walton MA, Winters J, Booth BM, Blow FC. Psychological aggression, physical aggression, and injury in nonpartner relationships among men and women in treatment for substance-use disorders. J Stud Alcohol Drugs. 2008 Nov;69(6):896-905. doi: 10.15288/jsad.2008.69.896.
PubMed 18925348Chermack ST, Murray RL, Walton MA, Booth BA, Wryobeck J, Blow FC. Partner aggression among men and women in substance use disorder treatment: correlates of psychological and physical aggression and injury. Drug Alcohol Depend. 2008 Nov 1;98(1-2):35-44. doi: 10.1016/j.drugalcdep.2008.04.010. Epub 2008 Jun 13.
PubMed 18554825Chermack ST, Grogan-Kaylor A, Perron BE, Murray RL, De Chavez P, Walton MA. Violence among men and women in substance use disorder treatment: a multi-level event-based analysis. Drug Alcohol Depend. 2010 Dec 1;112(3):194-200. doi: 10.1016/j.drugalcdep.2010.06.005. Epub 2010 Jul 27.
PubMed 20667666Chermack ST, Bonar EE, Ilgen MA, Walton MA, Cunningham RM, Booth BM, Blow FC. Developing an Integrated Violence Prevention for Men and Women in Treatment for Substance Use Disorders. J Interpers Violence. 2017 Feb;32(4):581-603. doi: 10.1177/0886260515586369. Epub 2016 Jul 11.
PubMed 26002873
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Violence Therapy for Substance Abusers
- ClinicalTrials.gov ID
- NCT00551863
- Acronym / sponsor ID
- R01DA017295-01A1
- Conditions
- Substance Use Disorders, Violence
- Keywords
- alcohol, drugs, aggression, substance use disorder treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 31 Oct 2007 (estimated)
- 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 purpose of this project is to develop and pilot test a violence prevention intervention for men and women in treatment for substance use problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVPT | Active comparator | Behavioral: IVPTIntervention based on Motivational Interviewing and CBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of substance use related problems
- Interpersonal Violence history in the year before recruitment
Key exclusion criteria (3 listed)
- Primary opiate dependence
- Presence of active psychotic disorder
- < 18 years of age
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 |
|---|---|---|
| IVPTViolence prevention intervention based on Motivational Interviewing and CBT | Behavioural | IVPT |
Primary outcome
Interpersonal Violence
Time frame: 3 and 6 month follow-up
1 secondary outcome
alcohol and drug use
Time frame: 3 and 6 month follow-up
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 7 Aug 2015.
- Background: PubMed 25012548Epstein-Ngo QM, Walton MA, Sanborn M, Kraus S, Blow F, Cunningham R, Chermack ST. Distal and proximal factors associated with aggression towards partners and non-partners among patients in substance abuse treatment. J Subst Abuse Treat. 2014 Oct;47(4):282-92. doi: 10.1016/j.jsat.2014.05.005. Epub 2014 Jun 10.
- Background: PubMed 18977093Ilgen MA, Chermack ST, Murray R, Walton MA, Barry KL, Wojnar M, Blow FC. The association between partner and non-partner aggression and suicidal ideation in patients seeking substance use disorder treatment. Addict Behav. 2009 Feb;34(2):180-6. doi: 10.1016/j.addbeh.2008.10.004. Epub 2008 Oct 10.
- Background: PubMed 19938916Chermack ST, Murray RL, Winters JJ, Walton MA, Booth BM, Blow FC. Treatment needs of men and women with violence problems in substance use disorder treatment. Subst Use Misuse. 2009;44(9-10):1236-62. doi: 10.1080/10826080902960007.
- Background: PubMed 18925348Murray RL, Chermack ST, Walton MA, Winters J, Booth BM, Blow FC. Psychological aggression, physical aggression, and injury in nonpartner relationships among men and women in treatment for substance-use disorders. J Stud Alcohol Drugs. 2008 Nov;69(6):896-905. doi: 10.15288/jsad.2008.69.896.
- Background: PubMed 18554825Chermack ST, Murray RL, Walton MA, Booth BA, Wryobeck J, Blow FC. Partner aggression among men and women in substance use disorder treatment: correlates of psychological and physical aggression and injury. Drug Alcohol Depend. 2008 Nov 1;98(1-2):35-44. doi: 10.1016/j.drugalcdep.2008.04.010. Epub 2008 Jun 13.
- Background: PubMed 20667666Chermack ST, Grogan-Kaylor A, Perron BE, Murray RL, De Chavez P, Walton MA. Violence among men and women in substance use disorder treatment: a multi-level event-based analysis. Drug Alcohol Depend. 2010 Dec 1;112(3):194-200. doi: 10.1016/j.drugalcdep.2010.06.005. Epub 2010 Jul 27.
- Results publication: PubMed 26002873Chermack ST, Bonar EE, Ilgen MA, Walton MA, Cunningham RM, Booth BM, Blow FC. Developing an Integrated Violence Prevention for Men and Women in Treatment for Substance Use Disorders. J Interpers Violence. 2017 Feb;32(4):581-603. doi: 10.1177/0886260515586369. Epub 2016 Jul 11.
Related trials for Substance Use Disorders
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
Alcohol Use Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Not yet recruiting
Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for OUD
Opioid Use Disorder
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.
Stephen T Chermack, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IVPT in people with Substance Use Disorders and Violence, run by University of Michigan 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 2 inclusion and 3 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 7 Aug 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Interpersonal Violence (time frame: 3 and 6 month follow-up). 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 NCT00551863, which also lists 7 linked publications.
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 7 Aug 2015.