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Drug/Substance Abuse/AddictionPhase 2NCT01586689

Evaluating Alternative Aftercare Models for Ex-offenders

A Phase 2 study testing Oxford House, Safe Haven and Usual aftercare in people with Drug/Substance Abuse/Addiction and Alcohol Abuse/Addiction, run by National Institute on Drug Abuse (NIDA) 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 study is examining the relative effects of alternative aftercare models for ex-offenders who are recovering from substance abuse/addiction. The study is a longitudinal, randomized field trial that assigns participants to one of three conditions: Oxford House, a professionally-run residential treatment facility… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxford House, Safe Haven and Usual aftercare
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteUnited States
Study dates
Sep 2006to Jun 2013
Phase
Phase 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

  • released from prison/jail in last 24 months
  • recovering from alcohol or drug dependence

Who cannot join

  • convicted of violent crime such as murder, aggravated assault
  • currently using alcohol or drugs

Trial locations and contacts

1 site in 1 country.

United States1 site

  • DePaul University

    Chicago, Illinois, 60614

Other trials in United States

About this study

This study is examining the relative effects of alternative aftercare models for ex-offenders who are recovering from substance abuse/addiction. The study is a longitudinal, randomized field trial that assigns participants to one of three conditions: Oxford House, a professionally-run residential treatment facility, or a control condition that involves usual aftercare chosen by participants (which may include no treatment at all). Oxford Houses are self-run residential recovery homes based on the premise of mutual support. These homes do not involve professional treatment staff and the expenses (e.g. rent, utilities) are paid for by the residents. The hypothesis of this study is that Oxford House participants will have as good or better outcomes in terms of substance recovery, recidivism, and health in comparison to the participants who were assigned to the residential treatment facility, and better outcomes in comparison to the control group. In addition, the cost to government/tax payers will be substantially lower given that participants pay their own way.

Being tested
Oxford House, Safe Haven, Usual aftercare
Keywords
Oxford House, recovery, substance abuse, alcohol abuse, addiction
Medical subject headings
Behavior, Addictive, Alcoholism, Substance-Related Disorders

What participants receive

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

  • Oxford HouseBehavioural

    community-based recovery home for participants recovering from substance dependency

  • Safe HavenBehavioural

    professionally-staffed treatment facility

  • Usual aftercareBehavioural

    control group - participants may or may not seek treatment on their own

Study groups in NCT01586689
Study groupRoleWhat they receive
Safe HavenExperimentalparticipants assigned to the Safe haven condition and agree to move into the A Safe Haven residential treatment facility
Receives: Behavioral: Safe Haven
Usual aftercareExperimentalparticipants assigned to the control condition, and may or may not seek treatment on their own
Receives: Behavioral: Usual aftercare
Oxford HouseExperimentalparticipants who were assigned to the Oxford House condition and agree to move into an Oxford House
Receives: Behavioral: Oxford House

What is being measured

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

  1. Relapse/recovery - drug test and self report of alcohol use

    An assessment of each participant's drug/alcohol use as determined by a urine test and report of alcohol use

    Measured: last data collection point (wave 5, 2 years after recruitment)

  2. recidivism

    whether or not the participant has been re-incarcerated, as indicated by Illinois Department of Corrections data base

    Measured: last data collection point (wave 5, 2 years after recruitment)

  3. health

    participant health, such as hospitalization and other indicators as measured by the Addiction Severity Index (ASI) - Light. also measures substance use, employment, legal system involvement, family and social life, psychiatric status.

    Measured: last data collection point (wave 5, 2 years after recruitment)

Secondary outcomes (2)

  1. Drug Taking Confidence Questionnaire (DTCQ)

    confidence to avoid using drugs and alcohol in various situations;

    Measured: every 6 months for 2 years

  2. Risk Behavior Survey

    recent substance use and sexual behaviors

    Measured: every 6 months for 2 years

Timeline

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

  1. First posted27 Apr 2012 (estimated)
  2. Study startSep 2006
  3. Primary completionJun 2013
  4. Study completionJun 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
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01586689
Sponsor's protocol ID
OHEO1
Status last verified
Sep 2014
First submitted
25 Apr 2012
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Jason, L.A., Olson, B.D., Mueller, D.G., Walt, L., & Aase, D.M. (2010). Residential recovery homes/Oxford Houses In B. White & J. Kelly (eds.) Addiction Recovery Management: Theory, Research and Practice. (pp. 143-161). New York: Humana Press.

  • Jason LA, Ferrari JR. Oxford House Recovery Homes: Characteristics and Effectiveness. Psychol Serv. 2010 May;7(2):92-102. doi: 10.1037/a0017932.

    PubMed 20577571

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxford House, Safe Haven and Usual aftercare in people with Drug/Substance Abuse/Addiction and Alcohol Abuse/Addiction, run by National Institute on Drug Abuse (NIDA) 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 2 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 12 Jan 2017. 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 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.

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?

Relapse/recovery - drug test and self report of alcohol use (time frame: last data collection point (wave 5, 2 years after recruitment)). 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?

On the ClinicalTrials.gov record for NCT01586689, which also lists 2 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 12 Jan 2017.

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