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

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) The Miriam Hospital
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00142935

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 is 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 will evaluate 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

MedlinePlus related topics: AIDS

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Opiate Replacement Therapy at Release From Incarceration

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Treatment engagement [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: No ]
Time to Treatment engagement from prison release [ Time Frame: 1.5, 6 month follow-up interivews ] [ Designated as safety issue: No ]
HIV risk behaviors [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Drug use [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: No ]
Fatal overdose [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: Yes ]
Non-fatal overdose [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	October 2005
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.	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 Resch Asst 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.
2: Experimental Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.	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.
3: Active Comparator Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.	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 is 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 will evaluate the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.

Participants in this 3-year study will be randomly assigned to 1 of 3 treatment groups. Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs. Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs. Participants enrolled in Group 3 will be referred to a program of choice upon release from incarceration without receiving financial assistance. All participants will have 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 will occur at Months 1.5, 6, 12 and 24. These will include 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

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

Contacts

Contact: Michelle Mckenzie, M.P.H.

(401)793-4790

mmckenzie@lifespan.org

Locations

United States, Rhode Island
The Miriam Hospital	Recruiting
Providence, Rhode Island, United States, 02906
Contact: Michelle Mckenzie, M.P.H. 401-793-4790 mmckenzie@lifespan.org

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

The Miriam Hospital

Investigators

Principal Investigator:

Josiah D Rich, M.P.H., M.D.

The Miriam Hospital

More Information

Responsible Party:	The Miriam Hospital/Warren Alpert Medical School of Brown University ( Josiah D. Rich, MD, MPH, Principal Investigator )
Study ID Numbers:	NIDA-18641-1, R01-18641-1, DPMC
Study First Received:	September 1, 2005
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00142935
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Methadone
Mental Disorders
HIV Infections
Acquired Immunodeficiency Syndrome

Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders

ClinicalTrials.gov processed this record on January 16, 2009