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Substance-related DisordersPhase 2/3NCT00700973

Treating Violence-Prone Substance Use Disorder Patients

A Phase 2/3 study testing Interpersonal Violence Prevention Intervention in people with Substance-related Disorders and Violence, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project is intended to help substance use disorder patients who perpetrate interpersonal violence against other adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance-related Disorders, Violence
What is being tested?
Interpersonal Violence Prevention Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
1 siteUnited States
Study dates
Feb 2009to Nov 2013
Phase
Phase 2/3
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

  • Entering VA substance use disorder treatment
  • past-year violence
  • cognitively intact

Who cannot join

  • Not entering VA substance use disorder treatment
  • no past-year violence
  • cognitively not intact

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1290

Other trials in United States

About this study

This project is intended to help substance use disorder patients who perpetrate interpersonal violence against other adults.

Read the detailed description

Background:

Interpersonal violence (IPV) among substance use disorder (SUD) patients is common, undertreated, and costly. SUD patients have high rates of perpetrating IPV, and IPV is a risk factor for poor response to SUD treatment. Failure to address IPV among SUD patients interferes with treatment effectiveness and contributes to relapse and higher rates of health services use. Nonetheless, SUD treatment programs typically do not include violence prevention interventions and few studies have examined interventions designed to prevent violence perpetration among SUD patients.

Objectives:

This trial evaluated the effectiveness of an IPV-prevention (IPV-P) intervention among patients entering VA SUD treatment who had perpetrated violence in the past year against another adult. Primary objectives were to test the hypotheses that, compared to patients assigned to a control condition (CC), those assigned to IPV-P would (1) improve more on violence and SUD outcomes, and (2) use fewer VA mental health and medical care services, thereby saving costs for VA. Secondary objectives were to test the hypothesis that, compared to patients assigned to CC, those assigned to IPV-P would improve more on legal and alienation problems and social resources.

Methods:

Patients entering VA SUD treatment who met eligibility criteria (past-year violence; cognitively intact) and provided informed consent were assigned to SUD usual care plus either a CC (N=60) or IPV-P (N=59) intervention using a recurrent institutional design. That is, the IPV-P and CC conditions were run in alternate 3-month periods. The manualized IPV-P group intervention, based on a Cognitive-Behavioral approach, consisted of 8 in-person group sessions over 1 month, followed by telephone calls once a month for 3 months. The manualized CC was designed to control for non-specific treatment effects associated with the IPV-P condition, i.e., counselor time and attention, peer support, patients' expectations that additional sessions provide benefit. It consisted of 8 in-person group sessions over 1 month that reviewed material covered in usual SUD treatment, but with novel methods used to deliver the IPV-P intervention (role-play, homework, group activities). CC included the booster telephone sessions (once per month for 3 months). Participants were assessed at baseline and end-of-intervention (4 months post-baseline) and 6 and 12 months post-intervention (i.e., 10 and 16 months post-baseline) for primary and secondary outcomes and non-VA healthcare. Assessments consisted of the Addiction Severity Index (ASI, to assess Alcohol, Drugs, Psychiatric, and Legal functioning), the Conflicts Tactics Scale (CTS, to assess Psychological Aggression and Physical Assault against another adult), the Multidimensional Personality Questionnaire (MDQ, to assess Alienation, Stress Reaction, and Aggression), and the Life Stressors and Social Resources Inventory (LISRES, to assess family and friends resources). VA health care is being assessed with VA databases. Response rates at 4, 10, and 16 months were 90%, 79%, and 73%, respectively, and did not differ between the IPV-P and CC groups. Follow-up analyses compared the IPV-P to the CC group on outcomes using analyses of covariance that controlled for the baseline value of the outcome.

Status:

We are still completing portions of this project: (1) conducting mixed effects regression analyses to compare the CC and IPV-P groups on primary and secondary outcomes (these analyses are partially completed), and (2) using data on VA health care utilization to compare the two groups on VA health care costs (permission to download these data has been obtained, and we are working with HERC investigators to download and analyze the data).

Being tested
Interpersonal Violence Prevention Intervention, Usual care
Keywords
anger, psychotherapy, brief, diagnosis, dual
Medical subject headings
Substance-Related Disorders, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interpersonal Violence Prevention InterventionBehavioural

    This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change.

  • Usual careOther

    Substance use disorder usual care

Study groups in NCT00700973
Study groupRoleWhat they receive
Arm 1Active comparatorSubstance use disorder usual care
Receives: Other: Usual care
Arm 2ExperimentalInterpersonal violence prevention intervention
Receives: Behavioral: Interpersonal Violence Prevention Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Addiction Severity Index Legal Composite

    Scores range from 0 to 1, with higher scores indicating more severe legal problems.

    Measured: One year post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionJan 2012
  4. Study completionNov 2013

Resources

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 2/3
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00700973
Sponsor's protocol ID
IIR 07-264
Status last verified
Feb 2014
First submitted
17 Jun 2008
Last updated
27 Apr 2015
Data monitoring committee
No

Publications

  • Timko C, Desai A, Blonigen DM, Moos BS, Moos RH. Driving while intoxicated among individuals initially untreated for alcohol use disorders: one- and sixteen-year follow-ups. J Stud Alcohol Drugs. 2011 Mar;72(2):173-84. doi: 10.15288/jsad.2011.72.173.

    PubMed 21388590
  • Blonigen DM, Timko C, Moos BS, Moos RH. Impulsivity is an independent predictor of 15-year mortality risk among individuals seeking help for alcohol-related problems. Alcohol Clin Exp Res. 2011 Nov;35(11):2082-92. doi: 10.1111/j.1530-0277.2011.01560.x. Epub 2011 Jun 1.

    PubMed 21631544
  • Makin-Byrd K, Cronkite RC, Timko C. The influence of abuse victimization on attendance and involvement in mutual-help groups among dually diagnosed male veterans. J Subst Abuse Treat. 2011 Jul;41(1):78-87. doi: 10.1016/j.jsat.2011.02.001. Epub 2011 Mar 10.

    PubMed 21396794
  • Timko C, Sutkowi A, Cronkite RC, Makin-Byrd K, Moos RH. Intensive referral to 12-step dual-focused mutual-help groups. Drug Alcohol Depend. 2011 Nov 1;118(2-3):194-201. doi: 10.1016/j.drugalcdep.2011.03.019. Epub 2011 Apr 22.

    PubMed 21515004

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Interpersonal Violence Prevention Intervention in people with Substance-related Disorders and Violence, run by US Department of Veterans Affairs 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 3 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 27 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2014). 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?

Addiction Severity Index Legal Composite (time frame: One year post-intervention). 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 NCT00700973, which also lists 4 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 27 Apr 2015.

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