CClinicalTrials.gg
Status unknownNCT00302575Updated Jan 11, 2017

Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees

An interventional study of Collaborative Behavioral Management and Integrated parole and outpatient addiction treatment in Substance-Related Disorders, sponsored by National Institute on Drug Abuse (NIDA). Status unknown at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-11.

Sponsored by National Institute on Drug Abuse (NIDA) · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The main purpose of this study is to examine whether improved integration between the community supervision system and outpatient addiction treatment system can improve treatment adherence, drug use and public safety outcomes among drug-involved inmates re-entering the community.

Read the detailed description

The target population consists of male and female parolees with a history of substance abuse treatment who are at moderate-to-high-risk of recidivism. They will recruited from in the criminal justice system and/or transitional residential drug treatment within one or two months of release or at the time they first report for parole supervision.

Participants from six states (KY, OR, RI, CT, VA, DE) will be randomized into the Step'n Out condition (integration of community supervision and addiction treatment with behavioral management) or a comparison condition including traditional community supervision and addiction treatment. Research interviews at baseline, and 3 and 9 months after release from confinement will assess study participants' outcomes.

The Step'n Out intervention will produce significantly better outcomes than the standard referral condition with respect to: recidivism rates (revocation, rearrest on a new charge, reconviction, reincarceration), as assessed 3 and 9 months after the end of the intervention; treatment participation (i.e., proportion of planned sessions attended, proportion of planned days retained in treatment, type of discharge [successful completion, transfer to another program, elopement, administrative discharge, return to custody], as assessed after the end of the intervention; self-reported drug use, criminal activity, and psychosocial functioning, as assessed 3 and 12 months after the end of the intervention; cost-effectiveness; collaboration between the supervision officer and treatment counselor ; and therapeutic alliance with the clients.

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Conditions studied

  • Substance-Related Disorders

Keywords

  • Substance-Related Disorders
  • Prisoners
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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 420 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. be at least 18 years old and speak English;
  2. have probable drug dependence immediately prior to incarceration as determined by a score of 3 or higher on the TCU Drug Screen II;
  3. be at moderate-to-high-risk of drug relapse and/or recidivism as determined by a Lifestyle Criminality Screening Form (LCSF) score of 7 or greater, or a history of 2 or greater prior treatments for drug-related problems or drug-related convictions;
  4. must have substance use treatment as a mandated or recommended condition of parole.

Exclusion criteria

Exclusion Criteria:

  1. psychotic features;
  2. parole or probation conditions that prohibit them from participating in the protocol.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
420 participants (estimated)

Interventions

  • BehavioralCollaborative Behavioral Management
  • ProcedureIntegrated parole and outpatient addiction treatment
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What researchers measure

Primary outcomes

  1. Rearrest

Secondary outcomes

  1. Drug use

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Study locations

3 of 5 sites recruiting
  • University of California, Los Angeles
    Los Angeles, California 90025, United States
    • William Burdon, PhD · Contact · wburdon@ucla.edu · 310-445-0874
    • Carter Bartee, BA · Contact · cbartee@ucla.edu · 503-241-7145
    • Michael Prendergast, PhD · Principal investigator
    Recruiting
  • Connecticut Deptartment of Mental Health & Addiction Services
    Hartford, Connecticut 06134, United States
    Recruiting
  • University of Delaware
    Newark, Delaware 19716, United States
    • Daniel J O'Connell, PhD · Contact · oconnell@UDel.Edu · 302-831-4649
    • Steven S. Martin, PhD · Principal investigator
    Recruiting
  • University of Kentucky
    Lexington, Kentucky 40536, United States
    • Conrad J Wong, PhD · Contact · conrad.wong@uky.edu · 859-323-6774
    • Carl G Leukefeld, DSW · Principal investigator
    Not yet recruiting
  • Virginia Commonwealth University
    Richmond, Virginia 23284, United States
    Not yet recruiting
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References and documents

Publications

  • Friedmann PD, Green TC, Taxman FS, Harrington M, Rhodes AG, Katz E, O'Connell D, Martin SS, Frisman LK, Litt M, Burdon W, Clarke JG, Fletcher BW; Step'n Out Research Group of CJ-DATS. Collaborative behavioral management among parolees: drug use, crime and re-arrest in the Step'n Out randomized trial. Addiction. 2012 Jun;107(6):1099-108. doi: 10.1111/j.1360-0443.2011.03769.x. Epub 2012 Feb 28. PubMed 22175445 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00302575
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted
Mar 14, 2006
Start date
Feb 2005
Completion
Aug 2007 (estimated)
Last update
Jan 11, 2017

Study contacts

Peter D Friedmann, MD, MPH
Contact
pfriedmann@lifespan.org
401-444-3347
Kristina Richards, MA
Contact
krichards@lifespan.org
401-444-5838
Peter D Friedmann, MD, MPH
principal investigator · Rhode Island Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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