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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00142935
First received: September 1, 2005
Last updated: May 8, 2014
Last verified: May 2009
  Purpose

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.


Condition Intervention
HIV Prevention
Opioid-Related Disorders
Behavioral: Pre-release Initiation of MMT
Behavioral: Post Release Initiation of MMT.
Behavioral: Standard of Care Plus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Opiate Replacement Therapy at Release From Incarceration

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Treatment Engagement [ Time Frame: within 30 days post release of incarceration ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 30 days post release from incarceration ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month follow-up interviews ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month follow-up interviews ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within six months from release of incarceration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 month follow-up interviews ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 87
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-Release Initiation MMT
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
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.
Experimental: Post Release Initiation of MMT
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.
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.
Active Comparator: Standard of Care Plus
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142935

Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Josiah D Rich, M.P.H., M.D. The Miriam Hospital
  More Information

No publications provided

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00142935     History of Changes
Other Study ID Numbers: NIDA-18641-1, R01-DA018641-1, DPMC
Study First Received: September 1, 2005
Results First Received: December 5, 2013
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by The Miriam Hospital:
HIV Prevention
Opioid-Related Disorders
Medication Assisted Treatment
Methadone

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014