search
Back to results

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

Primary Purpose

HIV Prevention, Opioid-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-release Initiation of MMT
Post Release Initiation of MMT.
Standard of Care Plus
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Prevention focused on measuring HIV Prevention, Opioid-Related Disorders, Medication Assisted Treatment, Methadone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Pre-Release Initiation MMT

Post Release Initiation of MMT

Standard of Care Plus

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Drug Use
Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.
Fatal Overdose
Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.
Non-fatal Overdose
Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.

Full Information

First Posted
September 1, 2005
Last Updated
May 8, 2014
Sponsor
The Miriam Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00142935
Brief Title
Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1
Official Title
Opiate Replacement Therapy at Release From Incarceration
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A substantial proportion of individuals addicted to heroin are incarcerated while addicted and a majority of individuals released from a correctional setting have a history of heroin addiction. The period immediately after release from incarceration is a particularly high-risk time for HIV transmission and other problems, including drug relapse and overdose. Methadone treatment is the most widely used opiate replacement therapy in the United States and has been shown to decrease HIV risk, as well as drug use, addiction relapse, and criminal activity. 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. Participants in this were randomly assigned to 1 of 3 treatment groups. Participants enrolled in Group 1 initiated methadone opiate replacement therapy about 1 month prior to release from incarceration. They proceeded with a methadone program of their choice upon release and received short-term payment to cover treatment costs. Participants enrolled in Group 2 were referred to a methadone program of their choice and received short-term payment to cover treatment costs. Participants enrolled in Group 3 were referred to a program of choice upon release from incarceration without receiving financial assistance. All participants had the opportunity to partake in existing support programs available at the Rhode Island Department of Corrections while incarcerated and in the community upon release. Follow-up assessments occurred at Months 1.5, 6, and 12. These included interviews and urine specimens for toxicology analysis to verify self-reports.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Prevention, Opioid-Related Disorders
Keywords
HIV Prevention, Opioid-Related Disorders, Medication Assisted Treatment, Methadone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Release Initiation MMT
Arm Type
Experimental
Arm Description
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.
Arm Title
Post Release Initiation of MMT
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care Plus
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pre-release Initiation of MMT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Post Release Initiation of MMT.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Engagement
Description
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.
Time Frame
within 30 days post release of incarceration
Title
Time to MMT Initiation Post Release Based on Clinic Chart Review
Description
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.
Time Frame
within 30 days post release from incarceration
Title
HIV Risk Behaviors - Self Report
Description
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.
Time Frame
6 month follow-up interviews
Secondary Outcome Measure Information:
Title
Drug Use
Description
Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.
Time Frame
6 month follow-up interviews
Title
Fatal Overdose
Description
Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.
Time Frame
Within six months from release of incarceration
Title
Non-fatal Overdose
Description
Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.
Time Frame
6 month follow-up interviews

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josiah D Rich, M.P.H., M.D.
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs