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

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ClinicalTrials.gov Identifier: NCT00142935
Recruitment Status : Completed
First Posted : September 2, 2005
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 87
Recruitment Details 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 There were no significant events following participant enrollment and prior to group assignment.
Arm/Group Title Pre-release MMT Initiation + Referral Post Release + Payment MMT Referral Post Release + Payment MMT Referral Post Release
Hide Arm/Group 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 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.
Period Title: Overall Study
Started 29 28 30
Completed 26 20 23
Not Completed 3 8 7
Reason Not Completed
Other reason             1             1             1
Lost to Follow-up             2             5             5
Death             0             2             1
Arm/Group Title Pre-release MMT Initiation + Referral Post Release + Payment MMT Referral Post Release + Payment MMT Referral Post Release Total
Hide Arm/Group Description 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 their choice upon release from incarceration without receiving financial assistance. Total of all reporting groups
Overall Number of Baseline Participants 29 28 30 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 30 participants 87 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
28
 100.0%
30
 100.0%
87
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 28 participants 30 participants 87 participants
37.3  (8.79) 37  (6.69) 38.4  (9.25) 37.6  (8.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 30 participants 87 participants
Female
10
  34.5%
8
  28.6%
9
  30.0%
27
  31.0%
Male
19
  65.5%
20
  71.4%
21
  70.0%
60
  69.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 28 participants 30 participants 87 participants
29 28 30 87
1.Primary Outcome
Title Treatment Engagement
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We assessed community methadone treatment clinic attendance of all enrolled participants based on clinic chart review.
Arm/Group Title As Assigned: Pre-release MMT + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Hide Arm/Group Description:
Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
Overall Number of Participants Analyzed 29 28 30
Measure Type: Number
Unit of Measure: participants
23 11 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection As Assigned: Pre-release MMT + Referral Post Release + Payment, As Assigned: MMT Referral Post Release + Payment, As Assigned: MMT Referral Post Release
Comments Outcome: engage in treatment post release, yes or no
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
2.Primary Outcome
Title Time to MMT Initiation Post Release Based on Clinic Chart Review
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants were analyzed as randomized (intent to treat). We calculated the mean number of days (and SD) between release from incarceration and first MMT clinic visit post release. Not all participants attended clinic within 30 days post release - those participants are not included in this analysis.
Arm/Group Title As Assigned: Pre-release MMT + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Hide Arm/Group Description:
Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
Overall Number of Participants Analyzed 23 11 6
Mean (Standard Deviation)
Unit of Measure: days
2  (4.37) 9  (9.74) 5  (5.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection As Assigned: Pre-release MMT + Referral Post Release + Payment, As Assigned: MMT Referral Post Release + Payment, As Assigned: MMT Referral Post Release
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
3.Primary Outcome
Title HIV Risk Behaviors - Self Report
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Assigned: Pre-release MMT + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Hide Arm/Group Description:
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 their choice upon release from incarceration without receiving financial assistance.
Overall Number of Participants Analyzed 25 16 21
Measure Type: Number
Unit of Measure: participants
3 6 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection As Assigned: Pre-release MMT + Referral Post Release + Payment, As Assigned: MMT Referral Post Release + Payment, As Assigned: MMT Referral Post Release
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .09
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
4.Secondary Outcome
Title Drug Use
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Assigned: MMT Pre-release + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Hide Arm/Group Description:
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 their choice upon release from incarceration without receiving financial assistance.
Overall Number of Participants Analyzed 25 16 21
Measure Type: Number
Unit of Measure: participants
6 8 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection As Assigned: MMT Pre-release + Referral Post Release + Payment, As Assigned: MMT Referral Post Release + Payment, As Assigned: MMT Referral Post Release
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .09
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
5.Secondary Outcome
Title Fatal Overdose
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Assigned: MMT Pre-release + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Hide Arm/Group Description:
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 their choice upon release from incarceration without receiving financial assistance.
Overall Number of Participants Analyzed 29 28 30
Measure Type: Number
Unit of Measure: participants
0 1 1
6.Secondary Outcome
Title Non-fatal Overdose
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Assigned: MMT Pre-release + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Hide Arm/Group Description:
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 their choice upon release from incarceration without receiving financial assistance.
Overall Number of Participants Analyzed 25 16 21
Measure Type: Number
Unit of Measure: participants
3 3 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection As Assigned: MMT Pre-release + Referral Post Release + Payment, As Assigned: MMT Referral Post Release + Payment, As Assigned: MMT Referral Post Release
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description Fatal Overdoses
 
Arm/Group Title As Assigned: Pre-release MMT + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Hide Arm/Group Description

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.

Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews.

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.

Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews.

Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.

Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews.

All-Cause Mortality
As Assigned: Pre-release MMT + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
As Assigned: Pre-release MMT + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      2/28 (7.14%)      1/30 (3.33%)    
Injury, poisoning and procedural complications       
Fatal Overdose *  0/29 (0.00%)  0 2/28 (7.14%)  2 1/30 (3.33%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
As Assigned: Pre-release MMT + Referral Post Release + Payment As Assigned: MMT Referral Post Release + Payment As Assigned: MMT Referral Post Release
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/26 (38.46%)      8/20 (40.00%)      8/23 (34.78%)    
Injury, poisoning and procedural complications       
Non-fatal Overdose  [1]  3/26 (11.54%)  3 3/20 (15.00%)  3 2/23 (8.70%)  2
ER visits  [2]  10/26 (38.46%)  10 7/20 (35.00%)  7 7/23 (30.43%)  7
Hospitalizations  [3]  4/26 (15.38%)  4 1/20 (5.00%)  1 1/23 (4.35%)  1
Indicates events were collected by systematic assessment
[1]
Any overdose reported by participants in the 12 month post release interview. These were not related to participation in the study.
[2]
Any ER visits that were reported by participants in the 12 month post release interview. These were not related to participation in the study.
[3]
Any hospitalizations that were reported by participants in the 12 month post release interview. These were not related to participation in the study.
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
Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00142935     History of Changes
Other Study ID Numbers: NIDA-18641-1
R01-DA018641-1
DPMC
First Submitted: September 1, 2005
First Posted: September 2, 2005
Results First Submitted: December 5, 2013
Results First Posted: June 6, 2014
Last Update Posted: June 6, 2014