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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
Results First Received: December 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HIV Prevention
Opioid-Related Disorders
Interventions: Behavioral: Pre-release Initiation of MMT
Behavioral: Post Release Initiation of MMT.
Behavioral: Standard of Care Plus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All recruitment occurred at the Rhode Island Department of Corrections. Screening began on 9/15/2006 and the first participant was enrolled on 9/29/2006. The last participant was enrolled on 2/20/2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no significant events following participant enrollment and prior to group assignment.

Reporting Groups
  Description
Pre-release MMT Initiation + Referral Post Release + Payment 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.
MMT Referral Post Release + Payment 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.
MMT Referral Post Release Participants assigned to this arm 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.

Participant Flow:   Overall Study
    Pre-release MMT Initiation + Referral Post Release + Payment     MMT Referral Post Release + Payment     MMT Referral Post Release  
STARTED     29     28     30  
COMPLETED     26     20     23  
NOT COMPLETED     3     8     7  
Other reason                 1                 1                 1  
Lost to Follow-up                 2                 5                 5  
Death                 0                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pre-release MMT Initiation + Referral Post Release + Payment 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.
MMT Referral Post Release + Payment 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.
MMT Referral Post Release Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
Total Total of all reporting groups

Baseline Measures
    Pre-release MMT Initiation + Referral Post Release + Payment     MMT Referral Post Release + Payment     MMT Referral Post Release     Total  
Number of Participants  
[units: participants]
  29     28     30     87  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     29     28     30     87  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  37.3  ± 8.79     37  ± 6.69     38.4  ± 9.25     37.6  ± 8.27  
Gender  
[units: participants]
       
Female     10     8     9     27  
Male     19     20     21     60  
Region of Enrollment  
[units: participants]
       
United States     29     28     30     87  



  Outcome Measures
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1.  Primary:   Treatment Engagement   [ Time Frame: within 30 days post release of incarceration ]

2.  Primary:   Time to MMT Initiation Post Release Based on Clinic Chart Review   [ Time Frame: within 30 days post release from incarceration ]

3.  Primary:   HIV Risk Behaviors - Self Report   [ Time Frame: 6 month follow-up interviews ]

4.  Secondary:   Drug Use   [ Time Frame: 6 month follow-up interviews ]

5.  Secondary:   Fatal Overdose   [ Time Frame: Within six months from release of incarceration ]

6.  Secondary:   Non-fatal Overdose   [ Time Frame: 6 month follow-up interviews ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Josiah D. Rich, MD, MPH
Organization: The Miriam Hospital/Brown University
phone: 401-793-4770
e-mail: jrich@lifespan.org


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