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Treatment for Opioid Dependent Offenders

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Opioid Dependence

Treatments

Drug: Methadone
Drug: buprenorphine (Suboxone)

Study type

Interventional

Funder types

Other

Identifiers

NCT01082679
H-2008-0242

Details and patient eligibility

About

This pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County. The questions addressed by future larger studies based upon the current pilot-feasibility study will center around whether access to primary health care as opposed to more traditional methadone treatment services will improve the health and criminal justice outcomes for participants.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • diagnosis of opioid dependence
  • opioid positive urine drug screen
  • participation in local Drug Treatment Court or Treatment Alternative Program
  • women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study

Exclusion criteria

  • current alcohol or sedative dependence
  • pregnancy
  • women who are currently breast-feeding
  • complex psychiatric co-morbidity (e.g. suicidality, psychosis)
  • complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
  • current pharmacotherapy with an agent which is contraindicated in combination with Suboxone or methadone according to drug labeling
  • paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 3 patient groups

methadone via specialty care
Other group
Treatment:
Drug: Methadone
Suboxone via specialty care
Other group
Treatment:
Drug: buprenorphine (Suboxone)
Suboxone via primary care
Other group
Treatment:
Drug: buprenorphine (Suboxone)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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