Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1

NCT00142935 | Completed Results DMC

• 4 other identifiers: NIDA-18641-1R01-DA018641-1DPMCR01DA018641
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to opiates. Many of these individuals pass through a correctional setting each year, creating an opportunity for linkage to substance abuse treatment. The purpose of this study was to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.

Conditions

HIV Prevention; Opioid-Related Disorders

Keywords

HIV Prevention; Opioid-Related Disorders; Medication Assisted Treatment; Methadone

Outcome Measures

Primary Outcomes (3)

• Treatment Engagement

  Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.

  within 30 days post release of incarceration

• Time to MMT Initiation Post Release Based on Clinic Chart Review

  Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.

  within 30 days post release from incarceration

• HIV Risk Behaviors - Self Report

  Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.

  6 month follow-up interviews

Secondary Outcomes (3)

• Drug Use

  6 month follow-up interviews

• Fatal Overdose

  Within six months from release of incarceration

• Non-fatal Overdose

  6 month follow-up interviews

Study Arms (3)

Pre-Release Initiation MMT

EXPERIMENTAL

Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.

Behavioral: Pre-release Initiation of MMT

Post Release Initiation of MMT

EXPERIMENTAL

Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.

Behavioral: Post Release Initiation of MMT.

Standard of Care Plus

ACTIVE COMPARATOR

Participants assigned to this arem will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.

Behavioral: Standard of Care Plus

Interventions

Pre-release Initiation of MMT BEHAVIORAL

Participants assigned to arm 1 will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.

Pre-Release Initiation MMT

Post Release Initiation of MMT. BEHAVIORAL

Participants assigned to Arm 2 will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.

Post Release Initiation of MMT

Standard of Care Plus BEHAVIORAL

Participants assigned to Arm 3 will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.

Standard of Care Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently incarcerated at the Rhode Island Department of Corrections with a scheduled release date at least 28 days after enrollment
• Incarceration length not to have exceeded two years at the time of enrollment
• Heroin dependent with self-reported heroin injection in the month prior to incarceration OR enrollment in a methadone treatment program prior to incarceration for heroin addiction with a history of injection drug use
• Desire to enter methadone treatment upon release and plans to secure funding for methadone treatment after study completion
• History of prior tolerance to methadone
• History of at least one drug-related incarceration
• Speaks English or Spanish
• Plans to remain in Rhode Island for the duration of the study (24 months)
• Ability to provide at least two names of individuals who can verify participant information

You may not qualify if:

• Currently receiving methadone at the Rhode Island Department of Corrections
• Currently undergoing a non-narcotic detoxification from illicit opiates at the Rhode Island Department of Corrections
• Plans to leave Rhode Island within the two years following enrollment

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Josiah D. Rich, MD, MPH
• Organization: The Miriam Hospital/Brown University

jrich@lifespan.org

401-793-4770

Study Officials

• Josiah D Rich, M.P.H., M.D.

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: September 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 6, 2014
• Results First Posted: June 6, 2014

Record last verified: 2009-05

Locations

US (1)